Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJohns Hopkins University
About this trial
Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise to secondary arthritis. This condition is associated with marked pain and loss of function, often necessitating a joint replacement. Due to the relatively young age of onset of ONFH (often in 20s and 30s), there is great interest in utilizing joint-preserving procedures prior to the need for joint replacement. Joint-preserving procedures include core decompression (CD) with and without bone grafts or cells, vascularized and non-vascularized bone grafting, as well as osteotomies. Inconsistent results for each of these procedures have been reported and there are no Clinical Practice Guidelines or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who have non-traumatic osteonecrosis of the femoral head
Only participants who have Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System
No evidence of subchondral fracture
All osteonecrotic lesion sizes
Disqualifiers
Participants diagnosed who have femoral head osteonecrosis for which no risk factor has yet to be identified
Participants will include all ethnicities and races
Be able and willing to participate in study and return for postoperative visits
Sickle Cell disease
Trial design
Design model
Parallel
Treatments tested in this trial
Core Decompression
Procedure/SurgeryStandard core decompression procedure is performed by drilling into the necrotic bone of the femoral head. A sham bone marrow aspiration involves advancing a needle to the iliac crest (no bone penetration, no bone marrow aspiration) through a small skin incision.
Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
Procedure/SurgeryThis involves bone marrow aspiration, concentrating the bone marrow aspirate, and injecting 6 milliliters of bone marrow aspirate concentrate into the necrotic femoral head through an opening created by the core decompression.
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Core decompression (CD)Active comparator 1 intervention
Group B: Bone Marrow Aspirate Concentrate (BMAC)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Radiological progression of osteonecrosis of the femoral head (ONFH) to ARCO Stage III or IV
The 2019 ARCO Staging System encompasses four stages. ARCO Stage I is the earliest stage of osteonecrosis and is characterized by a normal x-ray and an abnormal MRI. ARCO Stage IV is the most advanced stage of osteonecrosis and is characterized by findings of osteoarthritis on x-ray.
Time frame
Up to 24 months2
Change in Pain using the Pain VAS scale
This is assessed using the pain Visual Analogue Scale (VAS). The participant marks an X on a 10cm scale denoting the level of pain that they are experiencing. VAS measures pain intensity on a scale of 0 (no pain) to 10 (worst pain).
Time frame
Up to 24 months3
Time to failure of femoral head
Time is measured in months following the intervention (core decompression or core decompression with cells). Failure is defined as radiological progression to ARCO Stage III or IV or unremitting pain requiring surgical intervention.
Time frame
Up to 24 monthsSecondary outcomes
1
Change in Pain using the Hip disability and Osteoarthritis Outcome Score (HOOS)
The Pain subscale of the Hip disability and Osteoarthritis Outcome Score (HOOS) will be used. The HOOS Pain sub-score is comprised of 10 items with a potential total of 40 points. Higher score worse pain,
Time frame
Baseline, 6 months, 12 months, 24 months2
Change in Symptoms and Stiffness using the HOOS
The Symptoms and Stiffness will be assessed using the HOOS Symptoms and Stiffness sub-score is comprised of 5 items with a potential total score of 20 points. Higher score worse stiffness.
Time frame
Baseline, 6 months, 12 months, 24 months3
Change in Activities of Daily Living function using the HOOS
The HOOS Activities of Daily Living function sub-score is comprised of 17 items with a potential total of 68 points. Higher scores better functioning.
Time frame
Baseline, 6 months, 12 months, 24 months4
Change in Function in Sports and Recreational Activities using the HOOS
The HOOS Function of Sports and Recreational Activities subscale is comprised of 4 items with a potential total of 16 points. Higher score better outcome.
Time frame
Baseline, 6 months, 12 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov