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De effectiviteit van een kniebrace in de behandeling van artrose van de knie: een gerandomiseerde klinische studie.


- candidate number29453
- NTR NumberNTR7441
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2018
- Secondary IDsABRnr: 66797 
- Public TitleDe effectiviteit van een kniebrace in de behandeling van artrose van de knie: een gerandomiseerde klinische studie.
- Scientific TitleThe effectiveness of a valgus brace in the treatment of varus medial compartment osteoarthritis of the knee: a randomized clinical trial
- ACRONYMSecuTec OA brace versus no brace
- hypothesisOur 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. Hypothese: The management with brace is superior
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Varus knee, Valgus bracing, Medial compartment osteoarthritis
- Inclusion criteriaPatients 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 criteriaInsufficient 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-okt-2018
- planned closingdate22-jan-2021
- Target number of participants80
- InterventionsGroup 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 .
- Primary outcomeDifference in the VAS pain score at 6 months between the Bauerfeind SecuTec OA brace and controls receiving only conservative treatment.
- Secondary outcomeVisual 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.
- Timepointsbaseline, 2 weeks, 3 months, 6 months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Grinsven, van
- CONTACT for SCIENTIFIC QUERIES S. Grinsven, van
- Sponsor/Initiator Bauerfeind AG
- Funding
(Source(s) of Monetary or Material Support)
Bauerfeind AG
- Publications
- Brief summaryBackground of the study:
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 due to a higher revision rate in short and long term. Osteoarthritis of the knee is most often located in the medial compartment. 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. Valgus braces are designed to unload the medial compartment in order to decrease pain and improve function. 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. 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.

Objective of the study:
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.

Study design:
A multicentre randomized controlled clinical trial.

Study population:
Patients diagnosed with medial knee OA and a varus malalignment, aged between 40 and 70 years.

Intervention (if applicable):
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 .

Primary study parameters/outcome of the study:
Difference in the VAS pain score at 6 months between the Bauerfeind SecuTec OA brace and controls receiving only conservative treatment.

Secundary study parameters/outcome of the study (if applicable):
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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
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).
- Main changes (audit trail)
- RECORD22-aug-2018 - 2-sep-2018


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