Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis (UNIBRACE)

April 15, 2024 updated by: Thuasne

Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.

A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.

The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.

The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Friedrich-Wilhelm-Platz 5
      • Aachen, Friedrich-Wilhelm-Platz 5, Germany, 52062
        • Trauma Orthopedic Surgery Practice Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
  • Visual Analog Scale pain ≥ 40/100 in the last 48 hours
  • Signed informed consent prior to any study-mandated procedure.
  • Affiliated to the General regime of the Social Security or covered by a similar health insurance system

Exclusion Criteria:

  • Inability to walk or dependance on a wheelchair or use of crutches.
  • Diseases that do not allow participation in the study for a period of six weeks.
  • Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
  • Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
  • A body mass index over 35.
  • Successful Cortisone injection within the last four weeks before the start of the study.
  • Participation to any other clinical study which has an impact on the different endpoints.
  • Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
  • Inability to communicate in German.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I with UniRelieverTM offloading brace

Patients wearing the UniRelieverTM offloading brace (THUASNE):

For intervention group I, in addition to the usual care described above for the control group, patients will wear the studied UniRelieverTM offloading brace.
Device: UniRelieverTM offloading brace (THUASNE)
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
Experimental: Group II with Unloader One® X brace

Patients wearing the Unloader One® X brace (Össur):

For intervention group II, in addition to the usual care described above for the control group, patients will wear the Unloader One® X brace by Össur
Device: Unloader One® X brace (Össur)
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
No Intervention: Group III without orthosis

Patients wearing no orthosis:

In the control group, usual care is defined by:

  • buffer heel and/or
  • insoles and/or
  • outer edge raisin and/or
  • walking stick and/or
  • physiotherapy and/ or
  • analgesics oral and local depending on the patient's needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-free walking distance
Time Frame: 6 weeks
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee functional capacity
Time Frame: 6 weeks
The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe)
6 weeks
Pain on loading
Time Frame: 6 weeks
The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
6 weeks
Pain at rest
Time Frame: 6 weeks
The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
6 weeks
Analgesic consumption
Time Frame: 6 weeks
The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit .
6 weeks
Subjective range of movement
Time Frame: 6 weeks

The subjective knee range of movement is assessed qualitatively by having patients rate it as follow:

  • 'clearly improved',
  • 'improved',
  • 'unchanged',
  • 'deteriorated'
  • 'clearly deteriorated'.
6 weeks
Objective range of movement
Time Frame: 6 weeks
The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
6 weeks
Assessment of Patient's Global Impression of Change (PGI-C)
Time Frame: 6 weeks
Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference (better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
6 weeks
Assessment of compliance
Time Frame: 6 weeks
The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day.
6 weeks
Assessment of patient's satisfaction
Time Frame: 6 weeks
The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
6 weeks
Assessment of safety (AE and SAEs)
Time Frame: 6 weeks

The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits:

  • number,
  • type,
  • frequency,
  • intensity,
  • relationship with the study device
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thuasne

Collaborators

MED-RAS GmbH

Investigators

  • Principal Investigator: Michael Benning, MD, Trauma Orthopedic Surgery Practice Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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