ISRCTN50380458
Completed
N/A
Patellofemoral brace treatment in patients with chronic painful patellofemoral osteoarthritis (PFOA): a single centre randomised interventional treatment trial
niversity of Manchester (UK)0 sites144 target enrollmentMay 21, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Manchester (UK)
- Enrollment
- 144
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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