Abstract
Background:
Offloading knee braces can reduce pain and improve mobility in patients with knee osteoarthritis.
Objectives:
This study aimed to determine the effectiveness of the new UniReliever knee brace and to compare it to the widely used Unloader One X device.
Methods:
In this open-label, three-arm parallel-group randomized trial, 60 patients with medial knee osteoarthritis (Kellgren-Lawrence grade II‒IV), 34 male and 26 female with a mean age of 69.62 ± 9.57 years and mean body mass index of 26.86 ± 3.18 kg/m2, were recruited from an orthopedic center. The patients were randomly allocated to receive a UniReliever device, an Unloader One X device, or no knee brace (control). The primary outcome was the change in the pain-free walking distance from baseline to 6 weeks. Other measures included the Lequesne index, pain on exertion, range of motion, and analgesic use.
Results:
The mean pain-free walking distance more than doubled for the UniReliever group (from 2.0 ± 1.4 km to 4.6 ± 3.4 km) and the Unloader One X group (from 2.6 ± 2.3 to 5.6 ± 3.7 km), but not for the controls (from 1.3 ± 1.2 to 1.4 ± 1.3 km; comparisons with controls: p < 0.0001). The Lequesne index and pain on exertion also improved for the 2 knee brace groups (p < 0.05 for all comparisons with controls; p > 0.05 for comparisons between the knee brace groups), and the use of analgesics fell (UniReliever: 4/7 patients; Unloader One X: 8/11 patients; whereas controls: 1/9 patients). There were no serious adverse events.
Conclusions:
The UniReliever offloading knee brace can improve mobility and reduce pain in patients with medial knee osteoarthritis. The benefits are similar compared with the Unloader One X.
Trial registration:
Clinical Trials NCT05905809.
Keywords: pain, medial knee osteoarthritis, offloading knee brace, walking distances, functional impairment
Introduction
Knee osteoarthritis (OA) is a progressive disease of the knee joint and a leading cause of disability worldwide.1 It causes joint stiffness and pain that typically worsens after prolonged exercise. The risk of developing the disease increases with age, certain occupations, and excessive weight,2 and the prevalence is increasing.3
There is currently no cure for knee OA, but various treatment options exist, which aim to relieve pain and improve functioning. These include pharmacotherapy (e.g., intra-articular corticosteroid injections), physical exercise, and weight loss for overweight patients.4 In severe cases, knee arthroplasty may be required, although around 20% of patients do not have the desired clinical outcome after surgery.5 Orthoses have also been developed,6 most notably offloading knee braces. These devices redistribute weight away from the affected knee compartments, particularly the medial compartment, to relieve patients’ pain and improve their mobility. Several studies have shown that they can be highly effective,7-10 and they may also delay the need for surgery.11 However, there is evidence that these devices are only used by a minority of patients.12,13 With the increasing importance of nonpharmacological treatment in recommendations for OA, and the improvement in OA knee braces for reducing discomfort and increase fitting, the observance should be enhanced and orthoses should increase in use.6
Today we know that knee OA is characterized by cartilage degeneration coupled with marginal osteophytosis, subchondral bone remodeling, and inflammation of the synovial membrane. An association has been shown between the severity of cartilage erosion related to knee osteoarthritis by ultrasonographic evaluation and the clinical symptoms and functions.14 A recent publication reported a clinical relevance of structural effect after a mechanical treatment with unloading knee brace.15 The improvement of damaged cartilage seemed to be because of a decrease in the cartilage edema and to an increase in the concentration of proteoglycan and collagen. But further longitudinal studies with a larger sample size should be conducted to evaluate the association between symptomatic relief by using a knee brace and their impact on cartilage and joint structure by using quantitative measurements.
In this study, we assessed the performance of a new offloading knee brace for OA, the UniReliever (Thuasne, Paris, France). This was compared with a widely used knee brace, the Unloader One X (Össur, Reykjavik, Iceland), which has previously been shown to be effective for treating knee OA.8 The main aim was to demonstrate the superiority of the UniReliever device and the Unloader One X over no knee brace, and to demonstrate the noninferiority of the new device to the Unloader One X. The main outcome was the change in the pain-free walking distance from baseline to 6 weeks. The secondary aims were to determine the effects on knee functioning, pain, analgesic use, range of motion, and the patients' global impression of change. We also assessed patient satisfaction, compliance, and safety.
Methods
Trial design
This study was a single-center, interventional, prospective, randomized, controlled, open-label, three-arm parallel group study. The study was conducted in an orthopedic medical center in Germany. Ethical approval was obtained from the local ethics committee on May 31, 2023, and the study was registered on ClinicalTrials.gov (NCT05905809). The study was conducted in accordance with the Declaration of Helsinki and ISO 14155:2020. All patients provided written informed consent before taking part in the study. The results were reported in accordance with the 2010 CONSORT guidelines (Supplementary material, Supplemental Digital Content 1, http://links.lww.com/POI/A348).
Participants
Patients were included if they had been diagnosed with medial knee OA, which was classified as grade II–IV on the Kellgren-Lawrence scale.16 Patients were only included if they were 18 years of age or older, were covered by a health insurance scheme, and had experienced pain rated as 40 or more on a 100-mm visual analog scale over the last 48 hours. Patients were excluded if they were unable to walk or required a wheelchair or crutches; if they had other diseases that would affect their participation in the study; if they had concomitant ipsilateral patellofemoral OA or ipsilateral hip OA with more severe pain than for the medial knee OA; if they had a body mass index over 35 kg/m2; if they had received a cortisone injection that provided pain relief over the previous 4 weeks; or if they were participating in another clinical trial that could affect the outcome measures. Eligible patients were identified using the medical center's patient files, and they were invited to take part in the study by telephone. Patients were enrolled by the physician who conducted the trial.
Investigational device
The UniReliever (Thuasne) is a CE-marked, semi-rigid, offloading knee brace, which has an adjustable 3-point leverage system with inelastic straps. It has a TM5 hinge that replicates the natural movement of the knee, and silicon padding on the inner layer to ensure a close fit. The device redistributes weight away from the affected knee compartment and provides alignment support to reduce any varus/vagus thrust of the knee (Figure 1(a)).
Figure 1.
A, UniReliever semi-rigid offloading knee brace; (B) unloader one X offloading knee brace.
The comparison device was the Unloader One X (Össur; Reykjavik, Iceland), which also has a 3-point leverage system, and is widely used to treat patients with knee OA. This device has a bi-axial hinge as well as silicon padding on the inner layer (Figure 1(b)).
Randomization and procedure
Patients were randomly allocated to one of 3 groups in a 1:1:1 ratio. This was conducted by the study biometrician using the program randomizeR, and it was implemented by the principal investigator using opaque sealed envelopes.
At the inclusion visit, the patients received a UniReliever device, an Unloader One X device, or no knee brace (control), according to their allocated group. The patients who received a knee brace were instructed to wear the device for walking and physical exercise over a period of 6 weeks; they were also given a diary in which to record the number of hours the brace was worn each day as well as any analgesics taken and adverse events. Patients in all 3 groups received their usual care over the 6 weeks, which could include insoles, physiotherapy, and analgesics. Patients were asked not to take corticosteroids during the study. After 6 weeks, the patients returned for a follow-up visit.
Primary outcome measure: pain-free walking distance
The patients reported how far they could walk without pain at the inclusion visit (with no knee brace) and again at the 6-week follow-up (with the knee brace if they had received one). The change in walking distance served as the primary outcome measure.
Secondary outcome measures
At the inclusion visit and again at the 6-week follow-up, the patients completed the 11-item Lequesne index questionnaire to assess the severity of their functional impairment.17 They also reported their use of analgesics, and a goniometer was used to measure the range of motion of the knee with the Prone Knee Flexion Test (patients lying face down with their knees just off the end of the examination table when they flex the knee).18 The patients were also asked to go out for a 30-minute walk (wearing the knee brace at the 6-week follow-up, if they had received one) and then to indicate their level of pain on a numerical rating scale (0‒10).
At the 6-week follow-up, the patients completed additional measures. They rated their knee range of motion as “greatly improved,” “improved,” “unchanged,” “worsened,” or “greatly worsened.” They rated their global impression of change (symptoms, emotions, activity limitations, quality of life) on a seven-point scale ranging from “no change or condition has got worse” (1) to “a great deal better and a considerable improvement that has made all the difference” (7; Patient Global Impression of Change scale).19 Patients were also asked to rate the degree of change on a scale from −5 (much better) to +5 (much worse). They also completed a satisfaction questionnaire, which included several rating scales (e.g., fit, comfort). All adverse events were recorded.
Sample size
In a previous study,20 we found that the mean change in the pain-free walking distance after 2 months with no orthosis was 0.4 ± 0.8 km. For a mean change of around 1.25 km (approximate 3-fold increase) when using an orthosis, we calculated that 20 patients per group would be required (5% significance level; 90% power; same standard deviation; t test). For the comparison between the 2 knee brace groups, we calculated that 20 patients would be required per group for a one-tailed t test with 80% power and a noninferiority margin of −0.65 km. We, therefore, aimed to recruit 60 patients.
Statistical analyses
The analyses were run using SAS. The main study aims were hierarchically ordered, which meant that it was not necessary to adjust the significance level for the corresponding analyses. These were as follows:
To demonstrate the superiority of the UniReliever device over no knee brace.
To demonstrate the superiority of the Unloader One X device over no knee brace.
To demonstrate the noninferiority of the UniReliever device to the Unloader One X.
For the first analysis, we compared the change in the pain-free walking distance between the UniReliever group and the control group using a two-tailed t test (significance level: 5%). If this was significant, we then compared the Unloader One X group with the control group (two-tailed t test). If this was also significant, we then compared the UniReliever group with the Unloader One X group (one-tailed shifted t test).
For the pain measure, the Lequesne index, and the range of motion, we analyzed whether there were statistically significant differences between the 3 groups using linear mixed effects models, which included estimation of missing values (two-tailed tests, 5% significance level, SAS software, USA, version X64).
Results
Patients
A total of 60 patients with medial knee OA were recruited between June 7, 2023, and August 9, 2023; the last follow-up session was on September 20, 2023. The 3 groups of 20 patients were similar in their age (overall mean: 69.6 ± 9.6 years), sex (total: 26 females; 34 males), and BMI (overall mean: 26.9 ± 3.2; Table 1). All patients completed both the inclusion and 6-week follow-up sessions (Flow diagram, supplementary material, Supplemental Digital Content 1, http://links.lww.com/POI/A349).
Table 1.
Demographic and clinical characteristics of each group.
| UniReliever group, N = 20 | Unloader one X group, N = 20 | Control group, N = 20 | Total, N = 60 | |
| Age, y mean (SD) | 66.8 (9.5) | 70.5 (9.0) | 71.7 (10.0) | 69.6 (9.6) |
| Sex, N (%) | ||||
| Female | 9 (45) | 7 (35) | 10 (50) | 26 (43.3) |
| Male | 11 (55) | 13 (65) | 10 (50) | 34 (56.7) |
| BMI, kg/m2 | ||||
| Mean (SD) | 27.1 (2.9) | 26.9 (2.9) | 26.6 (3.8) | 26.9 (3.2) |
| Leg affected by medial OA, N (%) | ||||
| Left | 5 (25) | 12 (60) | 13 (65) | 30 (50) |
| Right | 15 (75) | 8 (40) | 7 (35) | 30 (50) |
| Grade of OA, N (%) | ||||
| II | 6 (30) | 1 (5) | 0 | 7 (12) |
| III | 10 (50) | 17 (85) | 13 (65) | 40 (67) |
| IV | 4 (20) | 2 (10) | 7 (35) | 13 (22) |
| Diagnosis, years ago | ||||
| Median (range) | 7.5 (0-30) | 5.0 (0-22) | 6.0 (1-20) | 5.5 (0-30) |
| Presumed causes of OA, N (%) | ||||
| Genetic predisposition | 18 (90) | 18 (90) | 18 (90) | 54 (90) |
| Excessive load on joints | 16 (80) | 17 (85) | 14 (70) | 47 (78) |
| Local inflammation | 2 (10) | 4 (20) | 2 (10) | 8 (13) |
| Previous joint injury | 3 (15) | 3 (15) | 3 (15) | 9 (15) |
BMI, Body Mass Index; OA, osteoarthritis.
Compliance
Most of the patients in the knee brace groups completed the diary (UniReliever group: 13/20 patients; Unloader One X group: 15/20 patients). The notes were analyzed and showed that the patients wore the UniReliever brace for 6.4 ± 0.3 days per week (mean ± SD), whereas this was 5.3 ± 0.4 days for the Unloader One X. The UniReliever group also wore the knee brace for more hours per day than the Unloader One X group (4.4 ± 2.8 vs. 3.1 ± 2.5 hours).
Main outcome measure
The mean pain-free walking distance greatly increased from baseline to 6 weeks for the 2 knee brace groups: from 2.0 ± 1.4 to 4.6 ± 3.4 km for the UniReliever group (+2.6 km), and from 2.6 ± 2.3 to 5.6 ± 3.7 km for the Unloader One X group (+3.0 km) (Figure 2). There was only a slight increase for the control group, from 1.3 ± 1.2 to 1.4 ± 1.3 km (+0.1 km). The change in the pain-free walking distance differed significantly between the UniReliever group and the control group (p < 0.0001), as well as between the Unloader One X group and the control group (p < 0.0001). The comparison between the 2 knee brace groups was not statistically significant (shifted t test: p = 0.3877), which meant that the noninferiority hypothesis could not be rejected. By inspecting the data for each participant, we noted that just 3 patients (2 in the Unloader One X group and one in the control group) were able to walk 5 km or more without pain at inclusion; by 6 weeks, this had increased to 10 patients (50%) in the UniReliever group and 9 patients (45%) in the Unloader One X group, whereas there was no change for the controls (one patient; 5%).
Figure 2.
Pain-free walking distance at baseline and 6 weeks. The mean values are shown with the standard deviations as error bars (N = 20 for each group).
Secondary outcome measures
Pain on exertion
The mean levels of pain after a 30-minute walk were much lower at 6 weeks than at baseline for the 2 knee brace groups, whereas this was not the case for the control group (Figure 3). The changes were analyzed using a random mixed effects model. The results showed significant differences between the control group and each knee brace group (p < 0.0001 for both), but no significant difference between the 2 knee brace groups (p = 0.3443).
Figure 3.
Pain on exertion. The mean levels of pain are shown, as assessed using a numerical rating scale from 0 to 10, with the standard deviations shown as error bars. Values are shown for the baseline and at the 6-week follow-up (N = 20 for each group).
Lequesne index
The mean scores on the Lequesne index remained relatively constant from baseline to 6 weeks for the control group, whereas an improvement of just under 2 points was seen for the knee brace groups (Figure 4). A random mixed effects model for the change in scores showed a significantly greater improvement for the 2 knee brace groups than for the controls (UniReliever group: p = 0.0094; Unloader One X group: p = 0.0313); there was no significant difference between the 2 knee brace groups (p = 0.5739).
Figure 4.
Lequesne index at baseline and 6 weeks. The mean values are shown with the standard deviations as error bars (N = 20 for each group). Note that a score of 0 indicates no functional impairment, 1‒4 indicates a mild impairment, 5‒7 indicates a moderate impairment, 8‒10 indicates a severe impairment, 11‒13 indicates a very severe impairment, and 14 or above indicates an extremely severe impairment.
Analgesic use
Around half of the patients took analgesics (mostly ibuprofen) at baseline (UniReliever group: 7/20; Unloader One X group: 11/20; control group: 9/20). Most of these patients reduced or stopped this medication if they received a knee brace (UniReliever group: 57.1% [4/7]; Unloader One X group: 72.7% [8/11]), whereas this was not the case for most controls (11.1% [1/9]). Several patients did not take any analgesics throughout the study: 13 patients (65%) in the UniReliever group, 9 patients (45%) in the Unloader One X group, and 11 patients (55%) in the control group.
Range of motion
Regarding the subjective measures, most patients in the knee brace groups reported that their range of motion had improved (UniReliever group: 85%; Unloader One X group: 80%), whereas this was not the case for the control group (0%). In contrast, the objective measures did not show any change for the Unloader One X group (mean: 113 ± 11°) or the control group (mean: 103 ± 12°), and only a 1° improvement for UniReliever group (mean: from 113 ± 13 to 114 ± 13°); there were no significant group differences (random mixed effects model: p = 0.5164 [control vs. Unloader One X], p = 0.2792 [control vs. UniReliever], and p = 0.6467 [Unloader One X vs. UniReliever]).
Patients' global impression of change
Most patients in the knee brace groups reported moderate or greater improvements (UniReliever group: 80%; Unloader One X group: 85%), whereas the controls did not report any improvement (Figure 5). The numerical ratings of change had mean values of −2.9 ± 1.8 for the UniReliever group, −2.7 ± 1.5 for the Unloader One X group, and 0.1 ± 0.2 for the controls.
Figure 5.
Patients' Global Impression of Change. The percentage of patients in each group who selected each of the possible responses for their global impression of change (N = 20 for each group).
Patient satisfaction
The results showed that the patients were generally satisfied with the knee braces in the ease-of-use, fit, aesthetics, and comfort (Table 2). Nearly all patients planned to continue using the device (18/20 (90%) for UniReliever and 19/20 (95%) for Unloader One X).
Table 2.
Patient satisfaction.
| UniReliever group, N = 20 | Unloader one X group, N = 20 | |
| Ease of putting on device (1: very difficult; 10: very easy), mean (SD) | 7.6 (1.2) | 7.2 (1.2) |
| Ease of removing device (1: very difficult; 10: very easy), mean (SD) | 8.1 (1.1) | 7.9 (1.0) |
| Fitting (1: very poor; 10: very good), mean (SD) | 7.1 (1.1) | 6.8 (0.9) |
| Ease of adjustment (1: very difficult; 10: very easy), mean (SD) | 8.0 (1.2) | 7.4 (1.2) |
| Frequency of adjustment, N (%) | ||
| Just when putting it on | 15 (75) | 17 (85) |
| 2‒5 times per day | 5 (25) | 3 (15) |
| >5 times per day | 0 (0) | 0 (0) |
| Aesthetics (1: extremely dissatisfactory; 10: highly satisfactory), mean (SD) | 6.0 (0.9) | 5.8 (1.1) |
| General comfort (1: very uncomfortable; 10: very comfortable), mean (SD) | 5.6 (0.9) | 5.9 (1.1) |
| Comfort at the back of the knee (1: very uncomfortable; 10: very comfortable), mean (SD) | 6.5 (1.1) | 6.1 (1.2) |
| Satisfaction with changes in knee pain (1: very dissatisfied; 10: very satisfied), mean (SD) | 7.9 (1.6) | 7.5 (1.2) |
| Plans to continue wearing brace, N (%) | ||
| No | 1 (5) | 1 (5) |
| Occasionally | 2 (10) | 3 (15) |
| A few days a week/every day | 17 (85) | 16 (80) |
| Likelihood of recommending knee brace to others (1: unlikely; 10: very likely), mean (SD) | 7.5 (1.7) | 7.2 (1.2) |
| Comparison with previous device, if relevant, N (%) | ||
| Much better | 9/12 (75) | 4/7 (57) |
| Somewhat better | 3/12 (25) | 3/7 (43) |
| Somewhat/much worse | 0 (0) | 0 (0) |
| Overall satisfaction (1: very dissatisfied; 10: very satisfied), mean (SD) | 7.9 (1.4) | 7.5 (1.3) |
Safety
For the UniReliever group, the patients' diaries showed that one patient had swollen veins on a foot, and another described muscle problems when using the device. For the Unloader One X group, 2 patients reported having irritated skin (one with blistering), 2 reported rubbing, and one reported swelling. One patient in each group reported that the device slipped. No serious adverse events were reported.
Discussion
This study supports the effectiveness of the new UniReliever device for treating medial knee OA, as it was found to markedly increase the pain-free walking distance. The improvements seen were striking, as the mean distance more than doubled, from around 2 km to over 4 km, whereas this remained unchanged for the controls. Similar benefits were seen for the comparison device, with no significant difference between the 2 knee braces.
The results of the secondary outcome measures were in line with the improved pain-free walking distance. Specifically, the levels of pain on exertion after a 30-minute walk were found to decrease for the patients who used a knee brace, and the use of analgesics fell for these 2 groups. In addition, the severity of the impairment, as assessed using the Lequesne index, was found to lessen, and the patients reported a global impression of improvement (PGI-C). Regarding the knee range of motion, subjective measures were rated as improved by the patients using a knee brace contrary to the objective measures assessed by the goniometer, which did not show any change. Globally, these results, therefore, further support the effectiveness of both the UniReliever device and the Unloader One X for treating medial knee OA.
Our findings are in line with previous studies on the Unloader One offloading knee brace. For instance, this brace has previously been shown to reduce patients' walking pain,21 and it has also been found to improve knee functioning compared with a look-alike device.8 Similar results have also been found for other knee braces, such as the Rebel Reliever.10 Our study, therefore, adds to a body of work supporting the clinical use of these devices, and further strengthens their recommendation in several guidelines.22-24
An important consideration for knee braces concerns patient compliance, as long-term use is generally envisaged to provide continued pain relief and improved mobility, as well as to delay or reduce the need for surgery.11 However, some previous studies have reported low rates of compliance. For instance, one study found that just 28% of patients regularly used a knee brace 12‒40 months after it was first fitted,25 and another study found that less than half still used their brace after 2.7 years.26 Reasons cited for the discontinuation included a poor fit, bulkiness, and difficulty putting the device on and taking it off.26 In our study, we found that there were high rates of compliance, as the patients reported wearing their brace most days of the week. However, the UniReliever device was worn for more hours per day (around 4) than the Unloader One X (around 3), which could potentially relate to differences in the design. For instance, the UniReliever straps cross at the side of the leg rather than at the popliteal fossa, which could improve the patients' comfort, particularly when sitting down. In addition, the TM5+ hinge on the UniReliever may also influence the levels of comfort. Despite these differences, we found that ratings of the fit, ease of use, and comfort were generally positive for both devices, and that comparisons with previous knee braces (GenuTrain from Bauerfeind, Genu-Tex from Sporlastic, CTi from Ossur, Push med knee brace from Push…) were all positive.
However, our data indicate that the knee braces used in this study could still be improved. There were complaints for both knee braces that included swelling and problems with the device slipping. Skin issues (irritation and rubbing) were also reported by 4 patients who wore the Unloader One X, but not by those who wore the UniReliever. This latter result may relate to differences in the silicon padding on the devices, as the UniReliever pads are designed to reduce sticking to the skin, which may lower the risk of irritation.
The limitations of this study include the relatively short duration and the lack of a look-alike knee brace for the control group. But a 6-week follow-up period was deemed sufficient and clinically relevant to demonstrate the clinical benefit of wearing the UniReliever semi-rigid offloading knee brace as it is expected to provide immediate improvement because of its biomechanical effect. Indeed, the brace is designed to apply corrective forces by means of a three-point pressure system and creating targeted offload. These corrective forces help distribute load away from the damaged compartment, resulting in immediate pain relief.
In addition, several outcome measures were subjective and so subject to bias, including the pain-free walking distance but Patient-Reported Outcomes correspond to validated measures to evaluate the benefit of medical devices for knee OA patients. Our study was also limited to patients with medial knee OA, and so the results may not generalize to patients with isolated lateral tibiofemoral or patellofemoral OA. Finally, there was no blinding; however, the large group differences are unlikely to be because of bias.
To conclude, our study supports the safety and effectiveness of the new UniReliever device for medial knee OA, and the results indicate that it has similar benefits to the Unloader One X. The results obtained in this study seem consistent with the favorable results provided by longer-term studies about the benefit of using of an orthotic treatment for the management of knee OA regarding pain, functional results, and quality of life.7,27 Although offloading knee braces are still little used in various parts of the world,12,13 this could potentially be improved by raising awareness of their effectiveness.28 This warrants further investigations in larger or longer clinical trials, in OA progression.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Thuasne (Paris, France).
Declaration of conflicting interest
The authors disclosed no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Study protocol: The full trial protocol is available from the authors upon reasonable request.
Supplemental material
Supplemental material for this article is available in this article. Direct URL citation appears in the text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.POIjournal.org).
Supplementary Material
Acknowledgments
We thank Jessica Foxton, PhD, from NewMed Publishing, Paris, for medical writing assistance. We thank MED-RAS for help with data management and the clinical report.
Contributor Information
Michael Benning, Email: m.benning@exinmo.de.
Alyssia Marques, Email: alyssia.marques@thuasne.fr.
Ralf-Dieter Hilgers, Email: rhilgers@ukaachen.de.
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