Our primary objective is to compare the short term (3 months follow-up) clinical and radiographic results of the Bledsoe Thruster Brace with the SofTec OA Brace in the management of patients with medial knee OA and a varus leg alignment.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in the VAS pain score at 3 months between the Bledsoe Thruster group
and the SofTec OA Brace group.
Secondary outcome
Visual Analogue Scale for pijn and satisfactio (VAS-pain, VAS-satisfaction),
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the
SF-12 and the 6-Minutes Walking Test at baseline, 2 weeks and 3 months.
Radiographs of varus leg alignment at baseline without brace and at 3 months
with brace.
Patients need to keep a diary once a week during the 3 months of participation.
In this diary they record mean daily analgesics use, complications and
compliance.
Background summary
Knee osteoarthritis (OA) is one of the most common joint disorders and is a
major cause of knee pain and immobility. Treatment can be non-operative or
operative. Operative treatment is not suitable for every patient, because of
medical comorbidity, old age or other circumstances. In young patients it is
desirable to delay primary arthroplasty. Osteoarthritis of the knee is more
located in the medial compartment. Patients with OA of the medial compartment
also often have a varus alignment and the varus deformity causes an overload of
the medial compartment with increasing symptoms during weight bearing.
Malalignment increases risk for progression of knee OA. Valgus braces are
designed to unload the medial compartment in order to decrease pain and improve
function. Recent systematic reviews concluded that there is very limited
evidence for the effectiveness of brace treatment for medial knee
osteoarthritis, mainly because of lack of randomized clinical trials. More than
30 commercially available braces are produced nowadays, with al kind of
different brace designs. To our knowledge no study has compared the
effectiveness of two different kind of braces as treatment of medial knee OA in
a randomized clinical trial.
Study objective
Our primary objective is to compare the short term (3 months follow-up)
clinical and radiographic results of the Bledsoe Thruster Brace with the SofTec
OA Brace in the management of patients with medial knee OA and a varus leg
alignment.
Study design
A multicentre prospective parallel-group randomized clinical trial.
Intervention
Intervention (if applicable): Trial arm 1: 3 month prescription of the Bledsoe
Thruster Brace. Trial arm 2: 3 month prescription of the SofTec OA Brace.
Study burden and risks
There are not many complication mentioned in the literature. Only minor skin
irritations, skin deficits and blisters. The only other expected problem is a
possible bad fit and discomfort of the brace. The extra burden associated with
participation in this study are the Visual Analogue Scale pain and
satisfaction, the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC), the SF-12 and the 6-Minutes Walking Test at baseline, 2 weeks
and 3 months and radiographs of varus leg alignment with brace at 3 months.
Patients need to keep a diary once a week during the 3 months of participation.
Wagnerlaan 55
6800 TA Arnhem
NL
Wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
Patients with medial knee osteoarthritis (confirmed on X-ray (AP and lateral) using the Kellgren classification).
Medial knee pain.
Varus leg alignment (confirmed on X-ray).
Age between 18-70.
Exclusion criteria
Insufficient command of the Dutch language.
The inability to apply brace because of physical or cognitive limitations.
Symptomatic back/hip/ankle/foot pathology (which makes improvement of pain, function, quality of life and satisfaction, by wearing a brace, impossible).
Other than osteoarthritis causing knee pain (like arthritis).
Pre-existing skin problems.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Het is aangemeld in het Nederlands Trial Register. We wachten nog op het registratienummer. |
| CCMO | NL32412.091.10 |