BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty

May 4, 2020 updated by: CAPRI Clinic

The Effectiveness of Bone Marrow Aspirate Concentrate (BMAC) in Patients With Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty - A Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Lacombe, Alberta, Canada
        • CAPRI Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
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)
Up to 12 months
30 second chair stand test
Time Frame: Up to 12 months
The maximum number of chair stand repetitions possible in a 30 second period
Up to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 months
Medication utilization
Time Frame: Up to 12 months
Medications used to control symptoms of the arthritic joint in the prior week
Up to 12 months
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?"
Up to 12 months
Reported complications/Adverse events
Time Frame: Up to 12 months
Descriptive list of any complications or adverse events
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAPRI Clinic

Collaborators

Alberta Bone and Joint Health Institute

Investigators

  • Principal Investigator: Rob Burnham, MD, CAPRI Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CTC-18-0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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