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Not yet recruiting NCT07439315

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

No phase Interventional Medial Compartment Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial joint distraction brace.
Who it may be relevant to
Registry conditions: Medial Compartment Knee Osteoarthritis. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Baseline, 2, 4, 8, 12 weeks]
  • European Quality of Life-5 Dimensions (EQ-5D-5L) [Time frame: Baseline, 2, 4, 8, 12 weeks.]
  • Visual Analogue Scale (VAS) [Time frame: Baseline, 2, 4, 8, 12 weeks.]
  • Functional Mobility Assessments [Time frame: Baseline, 2, 4, 8, 12 weeks]
  • Functional Mobility Assessment [Time frame: Baseline, 2, 4, 8, 12 weeks]
  • Functional Mobility Assessment [Time frame: Baseline, 2, 4, 8, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icarus Medical Innovations — Charlottesville

Publications

  • 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 Mar 7;13(6):1535. doi: 10.3390/jcm13061535. PMID 38541761
  • 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 May;30(5):747-53. doi: 10.1016/j.arth.2014.11.036. Epub 2014 Nov 29. PMID 25499679
  • Ciolino JD, Kaizer AM, Bonner LB. Guidance on interim analysis methods in clinical trials. J Clin Transl Sci. 2023 May 15;7(1):e124. doi: 10.1017/cts.2023.552. eCollection 2023. PMID 37313374
  • Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18. PMID 25035839
  • 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 Feb;85(2):142-9. PMID 15679465
  • 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. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93. PMID 18467932
  • 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. PMID 14613558
  • Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK589304/ PMID 36810025

Identifiers

NCT: NCT07439315 · 303260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗