BMAC in Severe Hip or Knee Osteoarthritis Awaiting Arthroplasty

NCT03908827 | Withdrawn Phase 2

• 1 other identifier: HREBA.CTC-18-0114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Randomized Clinical Trial; Osteoarthritis; Hip; Knee; Bone Mineral Aspirate Concentrate

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (3)

• Western Ontario and McMaster University Arthritis Index (WOMAC)

  Up to 12 months

• 40 meter fast-paced walk test

  Up to 12 months

• 30 second chair stand test

  Up to 12 months

Other Outcomes (4)

• Healthcare utilization

  Up to 12 months

• Medication utilization

  Up to 12 months

• Perceived need for joint arthroplasty: YES/NO

  Up to 12 months

Study Arms (2)

Active BMAC treatment

EXPERIMENTAL

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)

Wait List Control

NO INTERVENTION

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

Interventions

Bone Mineral Aspirate Concentrate (BMAC) BIOLOGICAL

A single BMAC injection will be performed into the arthritic joint

Active BMAC treatment

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAPRI Clinic: lead
• Alberta Bone and Joint Health Institute: collaborator

Study Sites (1)

CAPRI Clinic

Lacombe, Alberta, Canada

Location

Related Publications (17)

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• Pas HI, Winters M, Haisma HJ, Koenis MJ, Tol JL, Moen MH. Stem cell injections in knee osteoarthritis: a systematic review of the literature. Br J Sports Med. 2017 Aug;51(15):1125-1133. doi: 10.1136/bjsports-2016-096793. Epub 2017 Mar 3.

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• Chakravarthy K, Chen Y, He C, Christo PJ. Stem Cell Therapy for Chronic Pain Management: Review of Uses, Advances, and Adverse Effects. Pain Physician. 2017 May;20(4):293-305.

  PMID: 28535552 BACKGROUND

• Hegde V, Shonuga O, Ellis S, Fragomen A, Kennedy J, Kudryashov V, Lane JM. A prospective comparison of 3 approved systems for autologous bone marrow concentration demonstrated nonequivalency in progenitor cell number and concentration. J Orthop Trauma. 2014 Oct;28(10):591-8. doi: 10.1097/BOT.0000000000000113.

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• Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.

  PMID: 27566242 BACKGROUND

• Oliver K, Awan T, Bayes M. Single- Versus Multiple-Site Harvesting Techniques for Bone Marrow Concentrate: Evaluation of Aspirate Quality and Pain. Orthop J Sports Med. 2017 Aug 29;5(8):2325967117724398. doi: 10.1177/2325967117724398. eCollection 2017 Aug.

  PMID: 28890905 BACKGROUND

• Sugaya H, Yoshioka T, Kato T, Taniguchi Y, Kumagai H, Hyodo K, Ohneda O, Yamazaki M, Mishima H. Comparative Analysis of Cellular and Growth Factor Composition in Bone Marrow Aspirate Concentrate and Platelet-Rich Plasma. Bone Marrow Res. 2018 Feb 25;2018:1549826. doi: 10.1155/2018/1549826. eCollection 2018.

  PMID: 29682351 BACKGROUND

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  PMID: 27527475 BACKGROUND

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  PMID: 18697226 BACKGROUND

• Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH. A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther. 2011 May;41(5):319-27. doi: 10.2519/jospt.2011.3515. Epub 2011 Feb 18.

  PMID: 21335930 BACKGROUND

• Sun Y, Sturmer T, Gunther KP, Brenner H. Reliability and validity of clinical outcome measurements of osteoarthritis of the hip and knee--a review of the literature. Clin Rheumatol. 1997 Mar;16(2):185-98. doi: 10.1007/BF02247849.

  PMID: 9093802 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rob Burnham, MD

  CAPRI Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be blinded to treatment group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 9, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)