Evaluation of mesenchymal stem cells in the treatment of hip cartilage lesions post arthroscopic microfracture – prospective case series data collectio
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12615000257561
- Lead Sponsor
- Magellan Stem Cells
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria :
1.Radiological diagnosis of a hip cartilage lesion.
2.Primary treatment already undertaken defined as: analgesia/anti-inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella 2000), weight loss and nutritional management as prescribed by a dietician or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures as the first line of treatment (Thompson, Gordon et al. 2009).
3.Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.
Exclusion Criteria:
1.Age <18yrs. OA does not commonly occur in people under 18.
2.Pregnancy (accepted contra-indication as no safety data on this population).
3.Breastfeeding (accepted contra-indication as no safety data on this population).
4.Have other causes of their ankle symptoms suspected to be due to serious pathology such as tumour or referral from the lumbar spine. These conditions are not under investigation within the current project.
5.Current cancer.
6.History of significant organ impairment/failure (ie. renal failure).
7.History of allergy to any substances used within the treatments.
8.Bovine allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hip Injury and Osteoarthritis Outcome Score - <br>consists of 5 subscales being pain, other symptoms, function in daily living, function in sport and recreation and knee related quality of life. It is reliable and valid for the population of people with osteoarthritis.[Assessed at 0,1,3,6 and 12months post commencement of study.];0-10 Numerical Pain Rating Scale (NPRS) - The NPRS has been validated for use in people with hip osteoarthritis[Assessed at 0,1,3,6 and 12months post commencement of study.];MRI quantitative data including mapping of cartilage volume.[Assessed at commencement of study and again at 12months.]
- Secondary Outcome Measures
Name Time Method Global perceived effect scale. Measures of global effect are a recommended outcome measure for clinical trials[Assessed at 1,3,6 and 12months post commencement of study.<br>];Pain Treatment Satisfaction Scale - a validated questionnaire[Assessed at 1,3,6 and 12months post commencement of study.];The Orebro Musculoskeletal Pain Questionnaire will also be completed. This questionnaire has been to shown to be reliable and valid for detecting individuals at risk of developing persistent pain. This questionnaire will be used in the current study to assess the potential impact of psychosocial factors on participants’ outcome.[Assessed at commencement of study]