The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis

The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis

Study Overview

• Status: Not yet recruiting
• Conditions: Medial Compartment Knee Osteoarthritis
• Intervention / Treatment: Device: Medial joint distraction brace

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin M Koerber, PhD; Phone Number: 8147909364; Email: benk@icarusmedical.com
• Study Contact Backup: Name: Evan Eckersley; Phone Number: (570) 955-9662; Email: evan@icarusmedical.com

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Icarus Medical Innovations
      • Contact: Ben Koerber; Phone Number: 8147909364; Email: koerberbm1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 30-70, as significant knee OA is very common for people under 30, and would be more likely correlated to trauma.
• Able to ambulate with or without assistive devices
• Body-mass index (BMI) under 35. This is to minimize the effect of the variable of how the brace fits on the patient. The finding of pain relief will extrapolate to any BMI.
• Willingness and ability to comply with scheduled visits and study procedures
• Willingness and ability to fill out patient questionnaires written in English
• Ability to provide informed consent
• Clinical diagnosis of medial or lateral compartment knee osteoarthritis requiring a KO.
• Subject is suitable for unilateral bracing

Exclusion Criteria:

• Significant cognitive impairment interfering with study assessments
• Active infections or wounds at the foot or leg
• Severe spasticity that limits brace fitting or functioning
• History of severe lower limb deformities that would preclude brace use
• History of major joint surgery or joint implants, such as total knee replacement
• Other neurological or musculoskeletal conditions unrelated to the lower limbs that significantly impact gait
• Non-ambulatory
• Inability to travel for study procedures or fill out required surveys
• Medical conditions of interest
• Pregnant women
• Prisoners
• Clinical diagnosis of knee osteoarthritis that is not specific to the knee's medial or lateral compartment (multicompartmental, or patellofemoral knee osteoarthritis)
• Self-reported pain score of less than 3 out of 10 in the medial compartment.
• Varus or valgus deformity greater than 12°
• Inability to read/write/communicate in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis; Patients experiencing unicompartment (medial or lateral) osteoarthritis will receive Icarus Adonis Joint Distraction brace. Patients will wear the brace for 12 weeks and document how often they wear the brace and their pain scores. Patients will fill out outcome surveys at 2, 4, 6, 8, and 12 weeks.

Device: Medial joint distraction brace; Patients will receive Icarus Adonis Joint Distraction brace.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee	Baseline, 2, 4, 8, 12 weeks
European Quality of Life-5 Dimensions (EQ-5D-5L)	0 to 1, where 1 is perfect health	Baseline, 2, 4, 8, 12 weeks.
Visual Analogue Scale (VAS)	0-100, zero meaning no pain, 10 meaning severe pain	Baseline, 2, 4, 8, 12 weeks.
Functional Mobility Assessments	6 minute walk test	Baseline, 2, 4, 8, 12 weeks
Functional Mobility Assessment	5 times Sit to Stand test	Baseline, 2, 4, 8, 12 weeks
Functional Mobility Assessment	Timed Up and Go test	Baseline, 2, 4, 8, 12 weeks

Collaborators and Investigators

• Sponsor: Icarus Medical Innovations

Publications and helpful links

General Publications

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
• Stetter BJ, Fiedler J, Arndt M, Stein T, Sell S. Impact of a Semi-Rigid Knee Orthotic Intervention on Pain, Physical Activity, and Functional Capacity in Patients with Medial Knee Osteoarthritis. J Clin Med. 2024;13(6):1535. doi:10.3390/jcm13061535
• Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial. J Arthroplasty. 2015;30(5):747-753. doi:10.1016/j.arth.2014.11.036
• Ciolino JD, Kaizer AM, Bonner LB. Guidance on interim analysis methods in clinical trials. J Clin Transl Sci. 7(1):e124. doi:10.1017/cts.2023.552
• Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014;5(3):351-361. doi:10.5312/wjo.v5.i3.351
• Wilder FV, Barrett JP Jr. The Association Between Medication Usage and Dropout Status Among Participants of an Exercise Study for People With Osteoarthritis. Phys Ther. 2005;85(2):142-149. doi:10.1093/ptj/85.2.142
• Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res Int Z Rehabil Rev Int Rech Readaptation. 2008;31(2):165-169. doi:10.1097/MRR.0b013e3282fc0f93
• Devlin N, Pickard S, Busschbach J. The Development of the EQ-5D-5L and its Value Sets. In: Devlin N, Roudijk B, Ludwig K, eds. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide. Springer; 2022. Accessed November 20, 2024. http://www.ncbi.nlm.nih.gov/books/NBK589306/
• Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): A comprehensive set of clinical outcome instruments. doi:10.1080/03093640308726682
• Balkman GS, Bamer AM, Stevens PM, et al. Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses. PLOS ONE. 2023;18(11):e0293848. doi:10.1371/journal.pone.0293848
• Jm B, Pw S, Sa L. Lower Extremity Functional Scale (LEFS).
• Paluska SA, Mckeag DB. Knee Braces: Current Evidence and Clinical Recommendations for Their Use. Am Fam Physician. 2000;61(2):411-418.
• Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019;9(2):153-168. doi:10.1007/s13534-019-00094-z
• DeRogatis M, Anis HK, Sodhi N, et al. Non-operative treatment options for knee osteoarthritis. Ann Transl Med. 2019;7(Suppl 7):S245-S245. doi:10.21037/atm.2019.06.68
• McCormack DJ, Puttock D, Godsiff SP. Medial compartment osteoarthritis of the knee: a review of surgical options. EFORT Open Rev. 2021;6(2):113-117. doi:10.1302/2058-5241.6.200102
• Perdisa F, Bordini B, Salerno M, Traina F, Zaffagnini S, Filardo G. Total Knee Arthroplasty (TKA): When Do the Risks of TKA Overcome the Benefits? Double Risk of Failure in Patients up to 65 Years Old. Cartilage. 2023;14(3):305-311. doi:10.1177/19476035231164733
• Franklin PD, Suleiman L, Ibrahim SA. Racial/Ethnic and Sex Differences in Total Knee Arthroplasty Outcomes. JAMA Netw Open. 2020;3(5):e205000. doi:10.1001/jamanetworkopen.2020.5000
• Wang MC, Chan PH, Paxton EW, et al. Factors Influencing Patient Satisfaction With Care and Surgical Outcomes for Total Hip and Knee Replacement. Perm J. 2021;25:21.043. doi:10.7812/TPP/21.043
• Goodman SM, Mehta B, Zhang M, et al. Disparities in Total Hip Arthroplasty Outcomes: Census Tract Data Show Interactions Between Race and Community Deprivation. J Am Acad Orthop Surg. 2018;26(21):e457-e464. doi:10.5435/jaaos-d-17-00393
• Chun DS, Leonard AK, Enchill Z, Suleiman LI. Racial Disparities in Total Joint Arthroplasty. Curr Rev Musculoskelet Med. 2021;14(6):434-440. doi:10.1007/s12178-021-09718-3
• Losina E, Paltiel AD, Weinstein AM, et al. Lifetime medical costs of knee osteoarthritis management in the United States: Impact of extending indications for total knee arthroplasty. Arthritis Care Res. 2015;67(2):203-215. doi:10.1002/acr.22412
• Ezomo OT, Sun D, Gronbeck C, Harrington MA, Halawi MJ. Where Do We Stand Today on Racial and Ethnic Health Disparities? An Analysis of Primary Total Hip Arthroplasty From a 2011-2017 National Database. Arthroplasty Today. 2020;6(4):872-876. doi:10.1016/j.artd.2020.10.002
• Segal NA. Bracing and Orthoses: A Review of Efficacy and Mechanical Effects for Tibiofemoral Osteoarthritis. PM&R. 2012;4(5S):S89-S96. doi:10.1016/j.pmrj.2012.01.018
• Long H, Liu Q, Yin H, et al. Prevalence Trends of Site-Specific Osteoarthritis From 1990 to 2019: Findings From the Global Burden of Disease Study 2019. Arthritis Rheumatol Hoboken Nj. 2022;74(7):1172-1183. doi:10.1002/art.42089
• Alam M, Choudhury IA, Mamat AB. Mechanism and Design Analysis of Articulated Ankle Foot Orthoses for Drop-Foot. Sci World J. 2014;2014:867869. doi:10.1155/2014/867869
• Nori SL, Stretanski MF. Foot Drop. In: StatPearls. StatPearls Publishing; 2024. Accessed September 24, 2024. http://www.ncbi.nlm.nih.gov/books/NBK554393/
• KOBAYASHI E, HIRATSUKA K, HARUNA H, KOJIMA N, HIMURO N. EFFICACY OF KNEE-ANKLE-FOOT ORTHOSIS ON FUNCTIONAL MOBILITY AND ACTIVITIES OF DAILY LIVING IN PATIENTS WITH STROKE: A SYSTEMATIC REVIEW OF CASE REPORTS. J Rehabil Med. 2022;54:87. doi:10.2340/jrm.v54.87
• Bashir AZ, Dinkel DM, Pipinos II, Johanning JM, Myers SA. Patient Compliance With Wearing Lower Limb Assistive Devices: A Scoping Review. J Manipulative Physiol Ther. 2022;45(2):114-126. doi:10.1016/j.jmpt.2022.04.003

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Brace; Joint Distraction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 303260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD must be deidentified according to UVA IRB standard. If this would be the case then we would plan to share IPD and publish this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes