Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.
Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.
Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.
Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.
Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee brace group | Experimental | Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol). |
|
| Control Group | Active Comparator | Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valgus knee brace (Medex K39-OA Corrector) | Device | Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pain | Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control | At 16 weeks after the initiation of study |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in knee functioning | The Western Ontario and McMaster Universities Osteoarthritis Index | At 16 weeks after the initiation of the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith Hay-Man Wan, MBChB, FRCSEd(Orth) | Contact | +852 90384422 | keithayman@hotmail.com | |
| Siu Tong Choi, MBBS, FHKCOS | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Keith Hay-Man Wan, MBChB, FRCSEd(Orth) | Hospital Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Authority | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25756275 | Background | Fu HC, Lie CW, Ng TP, Chen KW, Tse CY, Wong WH. Prospective study on the effects of orthotic treatment for medial knee osteoarthritis in Chinese patients: clinical outcome and gait analysis. Hong Kong Med J. 2015 Apr;21(2):98-106. doi: 10.12809/hkmj144311. Epub 2015 Mar 10. | |
| 25201520 | Background | Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM. Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken). 2015 Apr;67(4):493-501. doi: 10.1002/acr.22472. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2019 | Aug 18, 2019 |
Not provided
Randomized prospective study
Not provided
Not provided
Outcome assessors are blinded from the treatment received
| Physiotherapy and oral analgesic (diclofenac and panadol) | Other | Physiotherapy and oral analgesic (diclofenac and panadol) |
|
| Prot_002.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D000700 | Analgesics |
| D004008 | Diclofenac |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided