Clinical trial NCT03908827: BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty
Official title: The Effectiveness of Bone Marrow Aspirate Concentrate (BMAC) in Patients With Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Randomized Clinical Trial
Osteoarthritis
Hip
Knee
Bone Mineral Aspirate Concentrate
Lead sponsor: CAPRI Clinic
Sponsor class: NETWORK
Collaborators: name: Alberta Bone and Joint Health Institute
First posted: 2019-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* symptomatic advanced unilateral knee or hip osteoarthritis (Kellgren-Lawrence grade 3 or 4) that is inadequately controlled with conservative management including physical therapy, bracing and/or oral anti-inflammatory medications
* completed an intake assessment by a Hip and Knee Clinic of the Alberta Bone and Joint Health Institute with the musculoskeletal physician and have been deemed to be a candidate for a knee or hip arthroplasty

Exclusion Criteria:

* unable to provide informed consent
* have religious or other objections to the use of blood or blood products
* will not be available for the projected 1 year follow up period
* at the time of treatment have a systemic infection or a localized infection at the area of injection
* have thrombocytopenia or are on antiplatelet, anti-inflammatory or statin medications that cannot be stopped for 1 week prior to and for 1 month following the treatment.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Up to 12 months
Secondary outcomes:
measure: Western Ontario and McMaster University Arthritis Index (WOMAC)
timeFrame: Up to 12 months
measure: 40 meter fast-paced walk test
timeFrame: Up to 12 months
measure: 30 second chair stand test
timeFrame: Up to 12 months
Other outcomes:
measure: Healthcare utilization
timeFrame: Up to 12 months
measure: Medication utilization
timeFrame: Up to 12 months
measure: Perceived need for joint arthroplasty: YES/NO
timeFrame: Up to 12 months
measure: Reported complications/Adverse events
timeFrame: Up to 12 months
Locations:
city: Lacombe
country: Canada
facility: CAPRI Clinic
state: Alberta
Study officials:
affiliation: CAPRI Clinic
name: Rob Burnham, MD
role: PRINCIPAL_INVESTIGATOR
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