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Completed

NCT Number: NCT05905809

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Behavior Health Behavior Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Rheumatic Diseases Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trauma Orthopedic Surgery Practice Center

Aachen, Friedrich-Wilhelm-Platz 5, 52062, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UniRelieverTM offloading brace (THUASNE)

Device

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

Unloader One® X brace (Össur)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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 .

  5. 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. 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)

  7. 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

  8. 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.

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Collaborators

  • MED-RAS GmbH

Registry information

Official study title

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

Acronym: UNIBRACE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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