A Phase 2/3 interventional study of Bone Mineral Aspirate Concentrate (BMAC) in Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by CAPRI Clinic. Withdrawn at 1 site in Canada. Open to participants aged 55 Years to 95 Years. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by CAPRI Clinic · Phase 2/3, Interventional, and Treatment
The prevalence of severe and disabling osteoarthritis of the hip and/or knee in Albertans is high and increasing. Existing nonsurgical treatments often inadequately control symptoms. Analgesic medications are frequently poorly tolerated in seniors. In these circumstances, joint arthroplasty remains the most evidence based definitive treatment option. In Alberta, wait times for orthopedic assessment and joint arthroplasty are unacceptably long. Additionally, there is a subset of patients who would benefit from joint arthroplasty but are not candidates because they are too young or are poor surgical candidates because of medical comorbidities. There is a great need for a clinically effective and cost-effective nonsurgical treatment option for severe knee and hip osteoarthritis.
There is a growing body of published studies consistently documenting a good safety profile for Bone Marrow Aspirate Concentrate (BMAC) injections. The risks and adverse events are comparable to injection of commonly used therapeutic agents (i.e. corticosteroid and hyaluronic acid), including joint swelling (this risk may be increased if the joint was previously affected by gout), stiffness, soreness and, very rarely, infection. The emerging literature also documents promising improvements in pain relief and function.
If intra-articular BMAC injection results in safe, significant and predictable relief of pain and disability in Albertans with severe hip and/or knee osteoarthritis, BMAC could offer an expeditious and cost-effective alternative to joint arthroplasty thus shortening arthroplasty wait times. Additionally, patients with severe osteoarthritis who are unfit for arthroplasty could be offered this less invasive intervention.
The aim of this trial is to evaluate the safety and effectiveness of BMAC injection in patients with severe hip or knee osteoarthritis.
This is a randomized controlled trial. In cooperation with Alberta Bone and Joint Health Institute (ABJHI), patients who have been deemed to be hip or knee joint arthroplasty candidates at the time of the initial assessment by the ABJHI musculoskeletal physician will be invited to participate. With the candidate's consent, they will be contacted by the study team, provided with additional information and an informed consent will be signed.
Participants will be randomized (by the project coordinator via computer generated simple randomization schedule) into either an active treatment (a single BMAC injection into the arthritic joint; n=75) or conservative care group (awaiting arthroplasty; n=75). The treatment group will receive their BMAC injection within 2 weeks of signing their consent form. 60 mL of bone marrow will be aspirated from the iliac crest of each subject in the active treatment group. The bone marrow aspirate (BMA) will be centrifuged using a single spin protocol such that the red blood cells are minimized and the total nucleated and platelet cells are concentrated into a 12 mL volume of bone marrow aspirate concentrate (BMAC). Two mL of BMA and BMAC will be retained for cellular analysis (total nucleated cells, platelet and hematocrit) injectate description purposes. Ten mL of BMAC will then be injected into the arthritic hip or knee. The bone marrow aspiration and joint injection will be done under local anesthesia, sterile technique and ultrasound or fluoroscopic guidance by a practitioner with ultrasound and fluoroscopy training/credentialing in an accredited Nonhospital Surgical Facility operating room in compliance with the College of Physicians and Surgeons of Alberta's (CPSA) Stem Cell Regenerative Therapy Standards. Each group will be allowed to take their usual analgesic medications (with the exception of the treatment group who will be asked to avoid NSAID intake for one week prior to and four weeks following their injection), receive their usual conservative treatments and each will be given the same activity instructions by ABJHI.
The active treatment group will be contacted by telephone within 3 days of their BMAC injection to monitor recovery and record and respond to any adverse events. Other outcome measures will be followed for 12 months (or until their joint arthroplasty surgery if prior to 12 months) and will be recorded by ABJHI who will be blinded to which treatment group the subjects are assigned. Outcome Measures will be measured in person at the time of enrollment into the study and at 6 months following post-treatment or non-treatment. At 3- and 12-months post, outcomes measures will be completed electronically or by phone. Only the assessor(s) will be blinded to the group assignment whereas the patient and the physician providing the treatment will be unblinded.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
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Exclusion Criteria:
60 mL of bone marrow will be aspirated from the iliac crest of each subject in the active treatment group. The bone marrow aspirate (BMA) will be centrifuged using a single spin protocol such that the red blood cells are minimized and the total nucleated and platelet cells are concentrated into a 12 mL volume of bone marrow aspirate concentrate (BMAC).
Biological: Bone Mineral Aspirate Concentrate (BMAC)
Participants will continue with their usual treatment, inclusive of medications or conservative treatments and will continue with activity guidelines as previously provided by clinical staff whilst awaiting joint arthroplasty
A single BMAC injection will be performed into the arthritic joint
Numeric Pain Rating Scale
Participants will be asked to rate the average pain severity for the prior week of the affected joint using a Numeric Pain Rating Scale (McCaffery \& Beebe, 1989). Participants will be asked to select the number that best represents their pain during the previous 24-hours on a scale of 0 to 10; with 0 indicating no pain and 10 indicating worst possible pain.
Time frame: Up to 12 months
Western Ontario and McMaster University Arthritis Index (WOMAC)
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Time frame: Up to 12 months
40 meter fast-paced walk test
A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft)
Time frame: Up to 12 months
30 second chair stand test
The maximum number of chair stand repetitions possible in a 30 second period
Time frame: Up to 12 months
Healthcare utilization
The number of physician and allied health professional visits relating to the treatment of joint pain in the prior month
Time frame: Up to 12 months
Medication utilization
Medications used to control symptoms of the arthritic joint in the prior week
Time frame: Up to 12 months
Perceived need for joint arthroplasty: YES/NO
"Given the problems you're having with your hip/knee at present, do you still want to have joint replacement surgery?"
Time frame: Up to 12 months
Reported complications/Adverse events
Descriptive list of any complications or adverse events
Time frame: Up to 12 months
Plan to share: No
This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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