Our primary objective is to compare the short and medium term (up to 6 months) clinical results in pain and function of the Bauerfeind SecuTec OA brace with only conservative treatment (no brace) in the management of patients with medial knee OA and…
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 6 months between the Bauerfeind SecuTec OA
brace and controls receiving only conservative treatment.
Secondary outcome
Visual Analogue Scale 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, 3 and 6 months. Patients need to keep a diary once a
week during the 6 months of participation (24 weeks). In the brace group,
patients record their analgesic usage, physical therapy usage, compliance and
adverse events. In the control group, analgesic usage and physical therapy
usage are recorded. After the final 6-month measurement, patients from the
intervention group (1) will be invited to undergo a 30-minute in-depth
semi-structured interview focussing on their perceptions about the (use of the)
brace.
Background summary
Knee osteoarthritis (OA) is one of the most common joint disorders and is a
major cause of knee pain and immobility (1, 2). 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 due to a higher revision rate in short
and long term (3, 4). Osteoarthritis of the knee is most often located in the
medial compartment (5). Patients with OA of the medial compartment also often
have a varus alignment.The varus deformity causes an overload of the medial
compartment with increasing symptoms during weight bearing. Malalignment
increases risk for progression of knee OA (6-9). Valgus braces are designed to
unload the medial compartment in order to decrease pain and improve function
(1, 10, 11). In recent years there have been numerous studies focussing on the
effectiveness of brace treatment for medial knee osteoarthritis. Despite
numerous studies, recent (systematic) reviews conclude that there is still
limited evidence of the effectiveness of brace treatment mainly because of poor
methodology and the absence of large randomized controlled clinical trials (12,
13). Therefore, we propose a methodological sound randomized controlled
clinical trial comparing the new Bauerfeind SecuTec OA brace to controls
receiving only a standard of care conservative treatment (14).
Study objective
Our primary objective is to compare the short and medium term (up to 6 months)
clinical results in pain and function of the Bauerfeind SecuTec OA brace with
only conservative treatment (no brace) in the management of patients with
medial knee OA and a varus leg malalignment.
Our secondary objective is to explore the intervention group patients*
perceptions about the (use of the) Bauerfeind SecuTec OA brace in terms of
activities, aesthetics, (dis)comfort/ergonomics, physical effects and
usability.
Study design
A monocenter randomized controlled clinical trial.
Intervention
Group 1: 6 months prescription of the Bauerfeind SecuTec OA brace in
combination with the standard conservative treatment containing of education
and analgetics / physical therapy if needed.
Group 2: 6 months standard conservative treatment containing of education and
analgesics / physical therapy if needed .
Study burden and risks
There are not many complications mentioned in the literature. Only minor skin
irritations, skin deficits, blisters and discomfort from wearing 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, 3 months and 6 months follow-up. Additionally,
patients are asked to fill out a diary once a week during the 6 months
participation (usage of analgesics and physical therapy, brace compliance and
complications).
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
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 40-70.
Exclusion criteria
Insufficient command of the Dutch language.
The inability to apply a 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.
OA confirmed Kellgren classification grade I or IV.
Systemic disease influencing the musculoskeletal system including among others
rheumatoid arthritis, fibromyalgia and systemic lupus erythematosus.
Body mass index above 35.
Distinct patellofemoral osteoarthritis.
Intra-articular injection with glucocorticosteroids combined with analgesics
within 3 months.
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 |
|---|---|
| CCMO | NL66797.091.18 |