Clinical trial NCT03454776: Unloader One Study on Knee Osteoarthritis Hässleholm Sweden
Official title: The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2018-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with same problem of osteoarthritis in knee
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: one year
measure: Knee Society Score (KSS)
timeFrame: one year
measure: Visual Analogue Scale (VAS)
timeFrame: one year
measure: EQ-5D
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Orthopeadic Clinic Hässlehlm Hospital
state: Skane
Study officials:
affiliation: Orthopeadic Clinic Hassleholm
name: Soren Toksvig-Larsen, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.