Inlay versus brace treatment for medial knee osteoarthritis: a randomised trial
| ISRCTN | ISRCTN92527149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92527149 |
| Secondary identifying numbers | NTR484; 3 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 12/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr T.M. Raaij, van
Scientific
Scientific
Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands
| t.vanraaij@chello.nl |
Study information
| Study design | Randomised open-label active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Inlay versus brace treatment for medial knee osteoarthritis: a randomised trial |
| Study acronym | SOLE |
| Study objectives | An inlay for the treatment of medial knee osteoarthritis will result in pain reduction, function improvement and better compliance then brace treatment. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Arthritis, Osteoarthritis |
| Intervention | Group 1: lateral wedge sole (inlay) Group 2: valgisation knee brace (brace) |
| Intervention type | Other |
| Primary outcome measure | Will inlay treatment for patients with symptomatic medial knee osteoarthritis yield better results then brace treatment? Measurements: 1. Painscore (VAS) 2. Hospital for Special Surgery (HHS) Knee Service Rating System 3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) |
| Secondary outcome measures | 1. Will there be a functional difference between both groups? Measurements: 1.1. Gait analysis (knee adduction moment, toeing-out, knee extension moment) 1.2. Knee range of motion 1.3. Patient satisfaction 1.4. Maximum walking distance 2. Will conservative treatment (inlay or brace) give a favourable outcome for medial knee osteoarthritis? Measurements: 2.1. Dual energy x-ray absorptiometry (DEXA-scan) 2.2. Osteoarthritis markers (serum and urine) 2.3. Hip-knee-ankle (HKA) angle |
| Overall study start date | 01/10/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Patients (male and female) with symptomatic medial osteoarthritis of the knee. Patients will be included after informed consent given and baseline measurements made. |
| Key exclusion criteria | 1. Below 35 or above 60 years of age 2. Symptoms not related to medial osteoarthritis of the knee 3. Not able to speak or understand Dutch. |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Hospital/treatment centre
Erasmus Medisch Centrum
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Algesiology Foundation (Stichting Algesiologie) (Netherlands)
No information available
The Anna Fonds Foundations (Stichting Anna Fonds) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No |
