Research in Osteoarthritis in Manchester (ROAM) Brace

Completed

Conditions: Topic: Musculoskeletal, Primary Care Research Network for England
Subtopic: Not Assigned, Musculoskeletal (all Subtopics)
Disease: Musculoskeletal, All Diseases
Musculoskeletal Diseases
Patellofemoral osteoarthritis

Registration Number: ISRCTN50380458

Lead Sponsor: niversity of Manchester (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 144

Inclusion Criteria

1. Age 40 - 70 years, either sex
2. Radiographic evidence of Kellgren-Lawrence score 2 or 3 predominating in the PF joint
3. Evidence of a bone marrow lesion on a clinical MR scan, or documented evidence of at least grade 2 arthritis on arthroscopy
4. Patellofemoral pain reproduced with stair climbing, kneeling or squatting but not with standing or walking on level ground
5. A nominated activity that causes worst pain which must be at least moderate in severity (i.e. should be greater than or equal to 4 on a 0 - 10 visual analogue scale [VAS])
6. Pain must have been present with this or other PF activities for the last 3 months
7. The patients will have lateral or medial patellar tenderness on palpation or a positive compression test
8. They should be on a stable medication regimen for 3 months (e.g. if the patients are using non-steroidal anti-inflammatory drugs [NSAIDs] there should be no change)
9. All participants must be willing to wear brace for 3 months daily
10. Potential subjects must have a treatable MRI feature also including either a bone marrow lesion in their PF joint (patella or opposing femoral trochlea) or synovitis on gadolinium scan

Exclusion Criteria

1. Previous patellar fracture or patellar realignment surgery
2. Predominant symptoms emanating from the tibiofemoral joint or from meniscal or ligament injury or if the patient has rheumatoid arthritis or other forms of inflammatory arthritis
3. If brace is not likely to work because the leg is too large
4. Intra-articular steroid injection into the painful knee in the last month or a viscosupplementation injection (such as Hyalgan, Durolane or Ostenil) with the last 3 months
5. If the patient is planning to move out of the area in next 3 months or will otherwise be unable to attend for follow up assessment
6. Those diagnosed with kidney disease or fatal disease
7. Usual exclusion criteria for the purposes of the MR scan

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS on nominated activity, measured at baseline, 6 weeks ,12 weeks and 18 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Aggregated Locomotor Function, measured at baseline, 6 weeks, 12 weeks and 18 weeks<br>2. Hip Abduction Strength, measured at baseline, 6 weeks, 12 weeks and 18 weeks<br>3. Knee injury Osteoarthritis Outcome Score (KOOS), measured at baseline, 6 weeks, 12 weeks and 18 weeks<br>4. Quadriceps Inhibition, measured at baseline, 6 weeks, 12 weeks and 18 weeks<br>5. Quadriceps strength (secondary), measured at baseline, 6 weeks, 12 weeks and 18 weeks