NCT03454776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

January 29, 2018

Last Update Submit

March 26, 2019

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    Standardized questionaire for knee problems, divided into 5 subscores of pain, symptoms, activity of daily living, sports/recreation and quality of life. Each subscore is presented from 0 (worst) to 100 (best).

    one year

  • Knee Society Score (KSS)

    Standardized outcome measure for knee problems presented in two subgroups of KSS Score and KSS Function, presented on a range from 0 (worst) to 100 (best)

    one year

  • Visual Analogue Scale (VAS)

    VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)

    one year

  • EQ-5D

    EQ-5D comprises two distinct self-report elements, providing three principal approaches to analysis(1) the EQ-5D profile: the patients' self reported health on the dimensions/levels of the descriptive system (2) the EQ-VAS: the patients' own global rating of their overall health, on a scale from 0 (worst possible health) to100 (best possible health)• Both types of data can be the focus of analysis, plus(3) Profiles can be summarized using 'value sets' (EQ-5DIndex) which reflect the preferences of the general public.

    one year

Study Arms (2)

Unloader One brace

ACTIVE COMPARATOR

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

Device: Unloader One brace

Placebo brace

PLACEBO COMPARATOR

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

Device: Placebo brace

Interventions

Unloader One braceDEVICE

A knee brace used to unload affected compartments in osteoarthritic knees

Unloader One brace
Placebo braceDEVICE

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

Placebo brace

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopeadic Clinic Hässlehlm Hospital

Hässleholm, Skåne County, 28138, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30243296DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Soren Toksvig-Larsen, Ass prof

    Orthopeadic Clinic Hassleholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with same problem of osteoarthritis in knee
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 29, 2018

First Posted

March 6, 2018

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

October 1, 2014

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

SE(1)