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Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis

NCT03410355 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-08

No results posted yet for this study

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

Interventions

PROCEDURE

BMAC/PRP Injection

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.

PROCEDURE

Cortisone Injection

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.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Ivan Wong, MD · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-05-17
Completion
2019-05-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410355 on ClinicalTrials.gov