Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis

NCT03410355 | Terminated

• 1 other identifier: IW-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of combined Bone marrow aspirate concentrate (BMAC) and Platelet Rich Plasma (PRP) action after a single hip intraarticular injection to young symptomatic patients with primary radiologic stage of hip OA (Kellgren-Lawrence grade I or II) compared to a control local anesthetic with cortisone injection group of patients. The hypothesis is that the patients with hip OA will benefit more and for longer from OA symptoms in the BMAC and PRP group rather than in the group of local anaesthetic and cortisone. Furthermore, this study could be valuable in determining the safety and effectiveness of the BMAC and PRP combined injection for early low grade hip OA in young active patients who are neither good candidates for total hip replacement nor preservative hip surgery.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Functional Benefit and Pain Level Changes using iHOT33 Questionnaire

  Assessment of functional benefit and pain level changes, using the International Hip Outcome Tool (iHot33) score at the 6-month time point post-injection, as well as, the pre-injection iHot33 score. The iHOT33 is a 33 question tool used to assess a patients ability to return to an active lifestyle through a subjective measurement of symptoms as well as emotional and social health status. Patients use a visual analog type scale (VAS) for each of the 33 questions to determine if activities are extremely difficult (to the left) to not difficult at all (to the right). Score is calculated as a mean on all VAS scores measured in millimeters, with 100 being the best score and 0 being the worst.

  6 months

Secondary Outcomes (4)

• Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS)

  6 months

• Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6 months

• Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12)

  6 months

• Pain Changes using the Visual Analogue Scale (VAS)

  6 months

Study Arms (2)

BMAC/PRP Injection Group

EXPERIMENTAL

This group will receive an injection of BMAC/PRP for treatment of OA

Procedure: BMAC/PRP Injection

Cortisone Injection Group

ACTIVE COMPARATOR

This group will receive an injection of cortisone for treatment of OA

Procedure: Cortisone Injection

Interventions

BMAC/PRP Injection PROCEDURE

Patients will be placed on an office procedure under local anesthesia. The investigators will harvest 60 cm3 of bone marrow from posterior iliac crest and centrifuged obtaining approximately 3 cm3 of autologous bone marrow-mesenchymal stem cells concentrate. At the same time, 60cm3 of peripheral blood will be taken and centrifugated once, to obtain approximately 3 cm3 of PRP. After activation of platelet rich plasma cells they will be mixed in one syringe with the concentrated BMaC and both will be injected in the hip joint under ultrasound.

BMAC/PRP Injection Group

Cortisone Injection PROCEDURE

An intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be injected in the hip joint under ultrasound.

Cortisone Injection Group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \<60 years old
• BMI of \<40 kg/m2
• Able to walk 50m unaided and not confined to a wheel chair
• Unilateral hip pain and radiographically and arthroscopically verified OA of the hip within the last 6 months (Kellgren-Lawrence grade I or II)
• HHS of less than 80
• Ability to understand the informed consent and participation instructions Attempted to use over the counter therapy without relief
• Able to participate for the entire protocol study period
• Able to follow physicians directions

You may not qualify if:

• Clinically significant OA in the contralateral hip
• Clinically significant pain in any other joint
• Have had intra-articular BMAC and or PRP injection within the preceding six months in the study hip
• Have had intra-articular steroid injection within the preceding three months in the study hip
• Have had previous surgical procedures on the affected hip within the preceding 6 months
• Have had a serious injury to the study hip within the previous 3 months
• Have had a serious psychological or medical condition that would interfere with their involvement
• Have had treatment with pain medications other than Tylenol and the drug remains in their system at the baseline or first study visit
• Have used of opioids other than weak opioids for OA pain more than 3 days/week within the last month
• Have used of systemic glucocorticoids (excluding inhaled steroids) within the preceding 3 months
• Treatment started with glucosamine/chondroitin sulfate or if the dosing has not been stable in the previous three months
• Has had a history of septic arthritis, skin infection or disease in the region of the injection site
• Currently using an anticoagulant excluding Aspirin 325 mg/day
• Uncontrolled diabetes
• Has any medical condition the principal investigator believes deems the patient unsuitable for the study

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E1, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Cortisone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ivan Wong, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon MD FRCS(C), Dip. Sports Medicine

Model Details: randomized control trial

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 25, 2018
• Study Start: February 1, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

CA (1)