BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03908827|
Recruitment Status : Withdrawn (Change of study design)
First Posted : April 9, 2019
Last Update Posted : May 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Osteoarthritis, Hip||Biological: Bone Mineral Aspirate Concentrate (BMAC)||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes Assessor will be blinded to treatment group allocation|
|Official Title:||The Effectiveness of Bone Marrow Aspirate Concentrate (BMAC) in Patients With Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty - A Randomized Controlled Trial|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Active BMAC treatment
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)
A single BMAC injection will be performed into the arthritic joint
No Intervention: Wait List Control
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
- Numeric Pain Rating Scale [ Time Frame: Up to 12 months ]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.
- Western Ontario and McMaster University Arthritis Index (WOMAC) [ Time Frame: Up to 12 months ]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.
- 40 meter fast-paced walk test [ Time Frame: Up to 12 months ]A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft)
- 30 second chair stand test [ Time Frame: Up to 12 months ]The maximum number of chair stand repetitions possible in a 30 second period
- Healthcare utilization [ Time Frame: Up to 12 months ]The number of physician and allied health professional visits relating to the treatment of joint pain in the prior month
- Medication utilization [ Time Frame: Up to 12 months ]Medications used to control symptoms of the arthritic joint in the prior week
- Perceived need for joint arthroplasty: YES/NO [ Time Frame: Up to 12 months ]"Given the problems you're having with your hip/knee at present, do you still want to have joint replacement surgery?"
- Reported complications/Adverse events [ Time Frame: Up to 12 months ]Descriptive list of any complications or adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908827
|Lacombe, Alberta, Canada|
|Principal Investigator:||Rob Burnham, MD||CAPRI Clinic|