Efficacy of non-operative treatment
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AbstractBackground: Recovery from knee surgery or injury can be hindered by knee arthrofibrosis, which can lead to motion limitations, pain and delayed recovery. Surgery or prolonged physical therapy are often treatment options for arthrof- brosis, but they can result in increased costs and decreased quality of life. A treatment option that can regain lost motion without surgery would help minimize risks and costs for the patient. The purpose of this study was to deter- mine treatment efficacy of high-intensity home mechanical stretch therapy in patients with knee arthrofibrosis. Methods: Records were reviewed for 11,000+ patients who were prescribed a high-intensity stretch device to regain knee fexion. Initial and last recorded knee fexion and days between measurements were available for 9842 patients (Dataset 1). Dataset 2 was a subset of 966 patients from Dataset 1. These 966 patients had separate more rigorous measurements available from physical therapy notes (Dataset 3) in addition to data from the internal database (Data- set 2). Within and between dataset statistics were calculated using t tests for comparison of means and Cohen’s d for determination of efect size. Results: All dataset showed signifcant gains in fexion (p<0.01). Mean initial fexion, last recorded fexion and fexion gain were 79.5°, 108.4°, and 29.9°, respectively in Dataset 1. Diferences between Datasets 2 and 3 had small efect sizes (Cohen’s d<0.17). The were no signifcant diferences when comparing workers’ compensation and non-workers’ compensation patients. The average last recorded fexion for all datasets was above the level required to perform activities of daily living. Motion gains were recorded in under 60 days from device delivery. Conclusions: High-intensity home mechanical stretch therapy was efective in restoring knee fexion, generally in 2 months or less, and in avoiding additional surgery in severe motion loss patients regardless of sex, age, or workers’ compensation status. We believe high-intensity stretching should be considered in any patient who is at risk for a secondary motion loss surgery, because in over 90% of these patients, the complications and costs associated with surgery can be avoided. Keywords: arthrofibrosis, Knee stiffness, Mechanical therapy, Non-operative treatment, High-intensity |
| Background Approximately 2 million patients undergo total knee arthroplasty or arthroscopic knee surgery each year in the United States [1, 2]. Te majority of these patients achieve a good clinical outcome including a return to | |
| *Correspondence: stinton@gmail.com 1 ArthroResearch LLC, 441 Armour Place NE, Atlanta, GA, USA Full list of author information is available at the end of the article |
| BMC LOGO | © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
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| functional range of motion (ROM) and pain-free activi- ties of daily living within 2 years of their surgery. How- ever, knee arthrofibrosis characterized by stiffness in the joint associated with motion loss can occur in some patients after knee surgery or injury. Tere are an esti- mated 85,000 patients who develop postoperative knee arthrofibrosis in the United States per year [3]. Te types of surgeries and the percentage of patients that have con- tinued severe motion loss beyond 1 year after that sur- gery (in parentheses) include: anterior cruciate ligament reconstruction (2–35%) [4], multiple ligament recon- struction (13–22.4%) [5], total knee arthroplasty (1.3– 12%) [6], tibial plateau fracture repair (14.5%) [7], and femur fracture repair (29.5%) [8]. A standard protocol of 6–8 weeks of physical therapy is efective in treating the majority of patients with arthrofibrosis [9]; however, outlier patients (those whose motion recovery does not respond to traditional physical therapy) can be left with marked loss of function and signifcantly increased healthcare costs due to arthrofibrosis. Patients with unresolved arthrofibrosis in the knee can develop severe, disabling pain and motion limitations that can interfere with activities of daily living [10]. Tese conditions sig- nifcantly delay recovery which, in turn, delays return to work or sport. When a patient’s motion loss recovery fails to respond to traditional physical therapy, a critical clinical pathway decision is reached. Currently, this decision is between a secondary surgery to manage excessive scar tissue forma- tion/motion loss or continued eforts to recover motion with traditional physical therapy. Many surgeons resort to the risk of secondary surgery such as a manipulation under anesthesia (MUA) with or without an arthroscopic lysis of adhesions which restarts the timeline of recovery and results in increased direct costs (secondary surgery, additional rehabilitation, and medication) and indirect costs (missed work) while reducing quality of life for the patient. In the United States, an MUA is required in up to 7.3% of total knee arthroplasty patients [11–19] and 11.3% of arthroscopic knee patients [20, 21]. A third option for recovery of motion loss due to arthrofibrosis is high-intensity home mechanical stretch (HIS) therapy which can help avoid prolonged physical therapy or secondary surgery. Te HIS device described in this study is hydraulically driven and is used in a patient’s home allowing the patient to apply a stretch to their knee multiple times per day up to a level of force that a physical therapist can apply in a clinical setting [22]. Tis high-intensity stretch is completely patient controlled with the stretch focused at the end-range of motion. Terefore, this device focuses on maximiz- ing total end range time (TERT), a product of intensity, frequency and duration of passive stretching, therefore, | encouraging plastic deformation of the soft tissue [23]. Te goal of HIS therapy is to achieve lasting gains in knee motion by permanently elongating scar tissue through load deformation. Te HIS device described in this study has been previ- ously shown to have a success rate of over 90% in both preventing a secondary surgery and in regaining func- tional ROM for severe motion loss patients [24, 25]. Te success rates associated with treatment using an HIS device show that patients with a severe fexion defcit have a high likelihood of regaining functional ROM. No complications have been reported using the HIS device, and therefore, this choice of treatment avoids the addi- tional costs and/or risks that are associated with motion loss surgery or prolonged physical therapy. While the earlier studies are promising, they are small in scale and data from a larger patient population are needed to vali- date the clinical beneft and potential cost savings from using HIS therapy. Terefore, the purpose of this retrospective study was to analyze data from more than 11,000 patients who uti- lized an HIS device to recover their knee fexion loss with the intent to determine treatment efficacy. Te primary hypothesis of the study was that patients treated with HIS therapy would achieve signifcant gains in knee fex- ion. Secondary hypotheses were that the motion gains would be sufcient for patients to avoid a secondary sur- gery and to perform activities of daily living. Methods Data collection Tis retrospective study was determined to be exempt from IRB review and a waiver of authorization was granted. Records from more than 11,000 patients who were prescribed an HIS device (the Ermi Knee Flexion- ater—Fig. 1) for motion recovery between 2008 and 2018 were reviewed. Patients who never received a device due to an insurance denial or that opted out of treatment were removed along with duplicate patients which left 9,842 patients for analysis (Dataset 1, as shown in Fig. 2). Documents in the internal database included clinical notes from doctors and physical therapists and other related documents, such as letters of medical necessity, intake paperwork, recertifcation paperwork, etc. Range of motion data were logged into the internal database during the process of treating the patients. In some cases, there was not a record of the exact date of each measure- ment and it was not known whether all measurements were taken with a goniometer. Te variables of interest were: (1) the knee fexion measurement taken closest to the time the device was delivered to the patient; (2) the last recorded knee fex- ion measurement; (3) the number of days between those |
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| measurements; and (4) the number of days between device delivery and the last recorded knee fexion meas- urement. Tese variables were extracted from each patient’s records in the internal database. | Device protocol Patients were prescribed an HIS device after reaching a plateau in their motion recovery after at least 4 weeks of treatment with a standard protocol of physical ther- apy. Tese patients were consistently unable to meet their individual knee fexion goals that were set by the patient and surgeon based on the injury type, surgi- cal procedure, contralateral knee fexion, age and sex of the patient, and pre-operative knee fexion. Patients used an HIS device to assist fexion stretching of their knee during three treatment sessions per day. During each session, the patient advanced the stretch to the maximum tolerable fexion, maintained the stretch for 10 min, and then released the stretch for 10 min. Tis was followed by another identical 10 min period of end- range stretch. Patients were instructed to stretch the joint to a level of discomfort just below the pain thresh- old. Te device included a hydraulic mechanism that allowed the patient to control the force of the stretch at variable loads and sensitivity up to a level equal to what is applied by a physical therapist [22]. Te patient’s own active involvement in stretching using the device and the precise control provided by the hydraulic mecha- nism allowed the patient to establish a kinesthetic sense and feedback that is unique when compared with other forms of mechanical therapy. Te patient could easily change the intensity of the stretch during the treatment period by pumping the device lever or using a quick- release mechanism. |
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| Subset datasets A subset of 966 patients taken from the larger Dataset 1 was defned as Dataset 2 (Fig. 2). Tis dataset only included the data from 966 out of 9842 patients, but the data for these 966 patients was the same between Data- set 1 and Dataset 2. Tese 966 patients were selected for the subset, because in addition to the records from the internal database, these patients also had more rigorous ROM data that were available from physi- cal therapy notes. Tese collected measurements were taken in various clinics by a physical therapist using a goniometer and included the date of the measurement. Tese physical therapy ROM measurements for the 966 patients were defned as Dataset 3. Te data were from patients that received the HIS device between 2010 and 2013. Data were aggregated from detailed reports that were previously prepared for physicians from select orthopedic clinics in Illinois, Texas and Florida or for payors including Independence Blue Cross Blue Shield (BCBS) in Pennsylvania, BCBS of Illinois, BCBS of Florida, and BCBS of North Carolina. Te initial recorded knee fexion was the measure- ment that was taken closest to the time of delivery of the HIS device. Further measurements were taken when a recertifcation of medical necessity was required, which was generally on a monthly basis. Te last recorded knee fexion was the most recent measure- ment available for each patient. Since the last recorded clinical measurement would be from the beginning of the last recertifcation period, the measurement is most likely lower than the patient’s fnal ROM after complet- ing treatment with the HIS device and could be sig- nifcantly lower in some patients. In each patient, the initial and last recorded measurements were required to be from the same source for consistency (i.e., the same physical therapy clinic). Tis allowed for more consistent reporting of ROM gains from patients treated at diferent locations. Passive ROM measurements (PROM) were preferred as more patients had PROM measurements available in their clinical notes and the measurements in the internal database were PROM; however, in a small percentage of patients (<5%), only a complete set of active ROM meas- urements (AROM) was available. In several instances, there were datasets with only one PROM and one AROM available. In such cases, the data was only used for analy- sis if the initial knee fexion measurement was a PROM measurement with an AROM measurement available for the second ROM and not vice versa. Since PROM is generally larger than AROM, in cases with PROM for the frst measurement and AROM for the second measure- ment, the patient’s improvement in ROM would most likely be underestimated, and not overestimated. | Exclusion criteria included: (1) Patients who did not have 2 sets of knee fexion measurements; (2) Patients who did not have an initial measurement taken within 30 days of device delivery; (3) Patients whose second measurement was not at least 10 days post-device deliv- ery; and (4) Patients who did not have at least 14 days between measurements. Since the subset of 966 patients had ROM data col- lected from two sources (internal database and physical therapy notes), these patients could be used to validate the fndings from the 9842 patients in Dataset 1 to see if the data collection methods for Dataset 1 were com- parable to the more rigorous data in Dataset 3 collected from physical therapy notes. Statistical comparisons were performed between the two datasets for the 966 patient subset (Dataset 2 and Dataset 3). Within dataset and between dataset statistics were calculated using t tests for comparison of means and Cohen’s d for determination of the efect size. Results Range of motion data Range of motion data for the 9842 patients in Dataset 1 are shown in Table 1. Te last recorded fexion was signif- icantly greater than the initial fexion (p<0.01). Range of motion data for the subset of 966 patients taken from the internal database (Dataset 2) and ROM data from physi- cal therapy notes (Dataset 3) are shown in Table 2. Te last recorded fexion was signifcantly greater than the initial fexion for both data sources (p<0.01). When Datasets 2 and 3 were compared using t tests, initial fexion, last recorded fexion, and gain in fexion were all signifcantly diferent. However, due to the large sample sizes, relatively small diferences were statistically signifcant. Te largest diference between the groups was in the initial range of motion (4.6° diference) but this only had a small efect size (Cohen’s d=0.16). Te aver- age initial fexion in both Dataset 2 and Dataset 3 was below the expected clinical level that would likely require a motion restoring surgery [26]. Te stricter inclusion criteria for the physical therapy data in Dataset 3 may contribute to this diference, because some of the initial measurements in the data from the internal database (Dataset 2) could have been taken a month or more prior |
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| to device delivery. Te patient may have been able to gain some knee fexion in physical therapy in that month which would not be refected if there was no documented measurement. Te last recorded fexion and the gain in fexion were similar between Datasets 2 and 3 with small diferences of 0.9° and 3.7° degrees, respectively. Both last recorded fexion and fexion gains had small efect sizes as calculated via Cohen’s d (0.04 and −0.14, respectively). Table 3 shows treatment efficacy based on the ini- tial range of motion of the patient. A lower starting range of motion results in a greater ROM gain on aver- age and a higher starting ROM corresponds to a higher last recorded ROM. In patients who started with≤60° of knee fexion, 76.2% reached at least 90 degrees of fexion. Tese patients are catastrophic patients who would oth- erwise undergo additional surgery and struggle to regain the ability to perform activities of daily living. Treatment time For the 9842 patients in Dataset 1, there were 8259 patients who had a date for both delivery of the HIS device and the end of device use. Te time between | device delivery and end of use averaged 75.4 days. Te vast majority (91.9%) of these patients used the device for a period of 4 months or less (3.8% treated for<30 days, 16.6% treated for 30–59 days, 43.1% treated for 60–89 days, and 28.4% treated for 90–119 days). Specifc dates for when the initial fexion measurement and last recorded fexion measurement were taken were not available for Dataset 1. After the initial measure- ment was taken, there was a fexion measurement taken for each month the patient used the device. Te 9842 patients in Dataset 1 required two recertifcations on average. Te standard protocol is to obtain a ROM meas- urement 8–12 days prior to the start of the next month of device use. Tis would mean the second recertifcation would occur approximately 50 days after device deliv- ery. Although it cannot be calculated, it is likely the time between measurements in the larger dataset was between 50 and 60 days. For the subset data for the 966 patients taken from physical therapy notes (Dataset 3), the time between the frst and last fexion measurement averaged 55.9 days and the time between device delivery and the last recorded measurement averaged 45.1 days. Tis means the initial measurement was taken an average of 10.8 days prior to device delivery. Tese time frames are in line with the estimated times for the larger Dataset 1 as described above. Te efect of the initial ROM on the days of use for the subset of patients in Dataset 3 is shown in Table 4. A lower initial ROM leads to longer use, but the largest dif- ference between the groups is less than 10 days. Demographic comparisons A comparison of ROM data between sexes is shown in Table 5. When comparing males and females, there was not a statistically signifcant diference in initial fex- ion, fexion gain, or days of use. Tere was a statisti- cally signifcant diference in the last recorded fexion with 2.0° higher fexion in males. All efect sizes were small as measured by Cohen’s d: initial fexion=0.01; last recorded fexion=0.10; fexion gain=0.06; days of use=0.09. |
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| A comparison of ROM data by age group is shown in Table 6. All age groups achieved a last recorded knee fexion that would allow them to complete most activi- ties of daily living [27, 28]. Tese gains were achieved in 2 months or less on average in all groups. Another interesting fnding in this study can be seen in the comparison between workers’ compensation patients and non-workers’ compensation patients. In the subset of 966 patients, there were 12 workers’ compen- sation patients. Data from physical therapy notes was available for 44 other workers’ compensation patients from the same time period (patients that were not in the larger dataset, because they did not have data in the internal database). Tose two sets of data were combined to create Dataset 4 (Fig. 2). Dataset 5 was made up of the 954 patients from Dataset 3 that were not workers’ | compensation patients. Tere were no signifcant difer- ences between Datasets 4 and 5 (Table 7). Tere were also no signifcant diferences between the 12 workers’ compensation patients and the 954 non-workers’ com- pensation patients in Dataset 3. Discussion Te most important fnding in this study is that regard- less of sex or age, patients with severe motion loss who were treated with high-intensity home mechanical stretch therapy achieved excellent gains in their range of motion (>25° on average). Tese gains were achieved |
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| over a relatively short period of time (6–10 weeks). As described by Keating et al., at least 90° of knee fexion is required to perform basic daily activities and the goal of an MUA after knee arthroplasty is to increase fexion in patients who have failed to reach 90° of fexion postop- eratively [26]. Patients in the current study achieved an average last recorded knee fexion that was well above the 90° that would typically be an indication for additional surgical intervention. Tis indicates that treatment using high-intensity home mechanical stretch therapy helped most patients avoid additional surgery and prolonged physical therapy. Te patients treated in this study were on a clinical pathway to be considered for surgical intervention with an MUA and/or lysis of adhesions. Te results of this study provide further evidence of the benefts of the more conservative option using the HIS device. Previous studies have shown this HIS device to be 90% efective in restoring a functional level of knee fexion (>110° of knee fexion) by the end of treatment which would allow the patient to perform activities of daily living [24, 25]. Tis previous fnding was reinforced by the current study, where the last recorded range of motion (not the knee fexion at the end of treatment) was already at the level required to perform activities of daily living. In both data sources for the 966 subset patents and in the larger data- set of 9842 patients (Datasets 1, 2 and 3), the average last recorded fexion is above the level of fexion required to perform activities of daily living (Navigating stairs—98°; Rising from a low chair—99°; Getting in and out of a car—105°; Tying shoelaces—106°) [27, 28]. For the ROM data taken from physical therapy notes in Dataset 3, more than 90% of patients achieved at least 90° of fexion at the last recorded ROM measurement (93.6%). While data reported in this study is PROM, the diference between AROM and PROM has been reported to be small in pre- vious studies of total knee arthroplasty patients [29–31]. Te largest diference between AROM and PROM in these studies was 4%. If that percentage was applied to the 110.7 ̊ of fexion that was the last recorded ROM for the subset patients, then knee fexion would still be 106.3 ̊ which would allow the patient to perform all the previously described activities of daily living. Tere would also be additional gains between the last recorded ROM and the fnal ROM at the end of treatment which would make it even more likely that the necessary knee fexion would be reached. While earlier studies exist examining the success of treating knee stiffness with other devices, these are all smaller scale studies [32–35]. To the best of our knowl- edge there are no similar retrospective large studies investigating the efficacy of other treatment options available for comparison. When comparing HIS therapy | to surgical intervention, the reported amount of fexion gained after open surgical release (43.3°) is comparable to gains from the current study and is between the 55.2° average gain made by the patients in the lowest starting ROM (≤60°) and the 32.7° average gain in patients with a starting ROM between 61 and 75° [36]. However, the gains from HIS therapy were achieved with none of the risks associated with surgical procedures. Manipulation under anesthesia is only 74% successful in reaching 90° of knee fexion [37]. Tere is also a critical diference in complications that can occur between the two treatment options. Tere have been no reported injuries related to the use of Ermi HIS devices in over 25 years of clinical use (FDA Maude database, company complaint logs). Complications after knee manipulation are rare, but can be devastating events, such as tibial plateau fracture, patellar ligament avulsion, pulmonary embolism, and death [21]. Previous studies have noted females are more likely to develop knee arthrofibrosis, and the current study also showed that trend (568 females vs. 398 males) [38, 39]. However, the current study did not fnd that sex infu- enced the likelihood of regaining ROM. A potential explanation for this is the HIS device allows each patient to stretch their own selected maximum threshold. Tis individualized treatment may counteract any sex difer- ences in recovery. Another beneft of having in home mechanical ther- apy as an adjunct to physical therapy is that physical therapists are not limited to working on restricted knee motion in the clinic but can also work on strength and neuromuscular re-education in the limited time avail- able. Te added value for these select severe motion loss patients is that they make mobility progress both in clinic and at home. Tis reduces bounce back motion loss between clinic visits which occurs in patients with- out the added home therapy using an HIS device as an adjunct. Tis allows the therapist to spend more time on other treatment modalities and contributes to the patient resuming their activities of daily living sooner and returning to work faster. Te fact that there were not any signifcant diferences in initial fexion, last recorded fexion, gain in fexion, or days between delivery and last recorded fexion between workers’ compensation patients and non-workers’ com- pensation patients is an important fnding. In general, workers’ compensation patients demonstrate signif- cantly worse outcomes from treatment when compared to non-workers’ compensation patients [40, 41]. Te rea- son for this is unknown, but could be due to a number of confounding variables, such as psychosocial factors, age, work demands, comorbidities, secondary gain issues, etc. However, none of these confounding variables have |
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| been shown to directly correlate with worse outcomes in workers’ compensation patients. Te results from this study suggest that the Knee Flexionater is an efective treatment modality for knee arthrofibrosis regardless of workers’ compensation status. Limitations Tere were several limitations with this study. First, the data was collected from a number of data sources and not via a single defned measurement protocol. Te range of motion data for the larger dataset of 9842 patients were taken from prescribing documentation. Tere was not a record of the exact date of each measurement in the internal database and it was not known whether all meas- urements were taken with a goniometer. However, data from the subset of patients were collected from physi- cal therapy progress notes, where both the patient’s frst and last measurements were taken at the same clinic, and were used to validate the data collection methods used for the larger dataset. While diferences in median ini- tial measured fexion, last measured fexion and fexion gains were noted between the two collection methods for the subset of 966 patients (5°, 2°,and 3°, respectively), the efect sizes were all considered to be small. As a result of the nature of the study and the large size of the data- set, confounders such as knee surgery type, preoperative knee ROM and duration of physical therapy could not be included. Terefore, future studies should also focus the infuence of these factors on regaining ROM using an HIS device. Conclusions High-intensity home mechanical stretch therapy was efective in restoring knee fexion, generally in 2 months or less, and avoiding additional surgery in severe motion loss patients as shown by excellent gains in knee fexion after treatment with the HIS device. Tis is true regard- less of sex, age, or workers’ compensation status. We believe high-intensity stretching should be considered in any patient who is at risk for a secondary motion loss sur- gery, because in over 90% of these patients, the complica- tions and costs associated with surgery can be avoided. | and manuscript preparation. All authors read and approved the fnal manuscript. Funding Ermi LLC paid expenses related to data analysis and manuscript preparation and submission. Availability of data and materials The datasets analyzed during the current study are not publicly available due to their ownership by a private company but are available from the cor- responding author on reasonable request. Declarations Ethics approval and consent to participate This retrospective study was determined to be exempt from IRB review and a waiver of authorization was granted. Consent for publication Not applicable. Competing interests TB is a paid employee of and has stock ownership in Ermi LLC. 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