Status:
TERMINATED
Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
16-60 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of combined Bone marrow aspirate concentrate (BMAC) and Platelet Rich Plasma (PRP) action after a single hip intraarticular injection to young sympt...
Detailed Description
The protocol will be applied to a blinded randomized controlled study. Patients who fit the inclusion criteria and have consented to the trial, will be randomized to receive a single injection of BMAC...
Eligibility Criteria
Inclusion
- Age \<60 years old
- BMI of \<40 kg/m2
- Able to walk 50m unaided and not confined to a wheel chair
- Unilateral hip pain and radiographically and arthroscopically verified OA of the hip within the last 6 months (Kellgren-Lawrence grade I or II)
- HHS of less than 80
- Ability to understand the informed consent and participation instructions Attempted to use over the counter therapy without relief
- Able to participate for the entire protocol study period
- Able to follow physicians directions
Exclusion
- Clinically significant OA in the contralateral hip
- Clinically significant pain in any other joint
- Have had intra-articular BMAC and or PRP injection within the preceding six months in the study hip
- Have had intra-articular steroid injection within the preceding three months in the study hip
- Have had previous surgical procedures on the affected hip within the preceding 6 months
- Have had a serious injury to the study hip within the previous 3 months
- Have had a serious psychological or medical condition that would interfere with their involvement
- Have had treatment with pain medications other than Tylenol and the drug remains in their system at the baseline or first study visit
- Have used of opioids other than weak opioids for OA pain more than 3 days/week within the last month
- Have used of systemic glucocorticoids (excluding inhaled steroids) within the preceding 3 months
- Treatment started with glucosamine/chondroitin sulfate or if the dosing has not been stable in the previous three months
- Has had a history of septic arthritis, skin infection or disease in the region of the injection site
- Currently using an anticoagulant excluding Aspirin 325 mg/day
- Uncontrolled diabetes
- Has any medical condition the principal investigator believes deems the patient unsuitable for the study
- Has any pathology of lumbar spine, sacroiliac (SI) joints, neuropathic or extra-articular hip pain
- Has a history of alcohol or drug abuse within the six months prior to enrolment in the study
- Has had a diagnosis of rheumatoid arthritis
- Has had a diagnosis of ankylosing spondylitis
- Has had a diagnosis of psoriatic arthritis
- Has had a diagnosis of reactive arthritis
- Has had a diagnosis of gout
- Has had a diagnosis of any connective tissue disease.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03410355
Start Date
February 1 2018
End Date
May 17 2019
Last Update
March 8 2022
Active Locations (1)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2E1