Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

NCT ID: NCT03454776

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a dummy.

Detailed Description

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy will be manufactured by Össur and has the same look as the real brace, but lacks the fundamental tightening effect of the straps of the real brace (an insert of elastic bands assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr. Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled studies have been conducted. This is mandatory if the effect of the brace and its use as an accepted treatment for knee OA is to be advocated for general use.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unloader One brace

Patients receiving an active brace, Unloader One with active straps facilitating unloading of affected knee compartment

Group Type: ACTIVE_COMPARATOR

Unloader One brace

Intervention Type: DEVICE

A knee brace used to unload affected compartments in osteoarthritic knees

Placebo brace

Patients receiving a dummy, lookalike or placebo brace without active straps that facilitate unloading of the affected knee compartment

Group Type: PLACEBO_COMPARATOR

Placebo brace

Intervention Type: DEVICE

A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee

Interventions

Unloader One brace

A knee brace used to unload affected compartments in osteoarthritic knees

Intervention Type: DEVICE

Placebo brace

A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patients fulfilling all criteria listed below will be considered to eligible for participation in the study:

• Patient, men and women, age 30 to 70 with knee OA not scheduled for surgery who understand the given information and are willing to participate in this study.
• Signed informed patient consent
• BMI < 35
• Knee pain for more than 3 month
• Patients with Knee OA Ahlbäck grade 1 and 2 and/or Kellgren-Lawrence 1 and 2
• Patient with arthroscopic OA but do not have regular grade 1 OA

Exclusion Criteria

Patient presenting with any of the following will not be included in the study:

• prior major surgery to the same knee
• patients with a history of stroke or neurological or psychiatric decease that potentially could affect the perception of pain
• obesity (BMI > 35)
• active or suspected infection
• patients taking opioids or steroids
• patients suffering from rheumatoid arthritis or have a immunological depression
• patients with other severe medical problems that could affect the perioperative course
• the patient had an intraarticular steroid injection in the actual knee during the last 3 months
• Patient participating in a clinical trial

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Sören Toksvig-Larsen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soren Toksvig-Larsen, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Orthopeadic Clinic Hassleholm

Locations

Orthopeadic Clinic Hässlehlm Hospital

Hässleholm, Skåne County, Sweden

Countries

Sweden

References

Hjartarson HF, Toksvig-Larsen S. The clinical effect of an unloader brace on patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up. BMC Musculoskelet Disord. 2018 Sep 22;19(1):341. doi: 10.1186/s12891-018-2256-7.

Reference Type: DERIVED

PMID: 30243296 (View on PubMed)

Other Identifiers

Orthosestudy

Identifier Type: -

Identifier Source: org_study_id