Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis (BMAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03410355|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip||Procedure: BMAC/PRP Injection Procedure: Cortisone Injection||Not Applicable|
The protocol will be applied to a blinded randomized controlled study. Patients who fit the inclusion criteria and have consented to the trial, will be randomized to receive a single injection of BMAC with PRP or local anesthetic with cortisone.
Patients will receive a clinical evaluation where they will complete the HHS, the WOMAC score, the VR-12 form, VAS score, and the two functional assessment tests to assess pain and function prior to the injection. The two functional assessments will be performed by the blinded researcher. Following the evaluation, the patients will receive an intra-articular hip injection.
Control group: In the second group of patients, an intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be performed in the same manner with the first group.
Experimental group: In the first group, 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. In all cases four samples of 0.2cm3 will be collected, one with patient's whole blood, one with the PRPs final mixture, one with whole bone marrow aspirate, and one with the BMaCs final mixture, and will be sent to the NSHA Hematology Laboratory for cell quantification. The leukocyte counts and differential (neutrophils, monocytes, lymphocytes, eosinophils and basophils) as well as thrombocyte counts in all samples will be determined using Automated Hematology Analyzer (Sysmex). Percentages of mature and immature leukocytes in the bone marrow aspirate and BMaC samples will be determined by standard morphologic examination using slides prepared with the Wright's stain. CD34+ stem cell enumeration in the bone marrow aspirate sample and BMaC will be performed by flow cytometry (Canto II Analyser).The concentration factor of PRP will be calculated from the quotient of the thrombocyte count in whole blood and in PRP. Additionally, IGF-I, VEGF, TGF-b, bFGF, HGF and PDGF will be quantified in serum or plasma and in PRP using commercially available ELISA kits (QuantikineH, ELISA KITS, R&D Systems, USA).
Clinic visits will occur at 6, 12, 24, and 48 weeks post-injection to perform clinical evaluations with outcome measures of the patients. All collected data will be statistically analyzed to check the effect of BMAC and PRP intraarticular hip injections in young patients with early OA. The investigators will also document the activity level of all participants (type of sport or activity participated in and the intensity and volume of participation) and correlate it with the outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized control trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcomes assessor will be blinded to the intervention|
|Official Title:||The Use of Bone Marrow Aspirate Concentrate in the Context of Hip Osteoarthritis: A Randomized Controlled Trial|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: BMAC/PRP Injection Group
This group will receive an injection of BMAC/PRP for treatment of OA
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.
Active Comparator: Cortisone Injection Group
This group will receive an injection of cortisone for treatment of OA
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.
- Functional Benefit and Pain Level Changes using iHOT33 Questionnaire [ Time Frame: 6 months ]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.
- Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS) [ Time Frame: 6 months ]The HHS is a widely used 10 item evaluation used to assess hip pain, function, hip deformity, and range of motion in patients who have total hip replacements, femoral neck fractures, and osteoarthritis. Each question is assigned a different numerical value. A score of 90-100 is excellent indicating minimal pain and excellent function, 80-89 is good, 70-79 fair, 60-69 poor, and below 60 a failed result.
- Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 6 months ]The WOMAC is a 24 item evaluation used in hip or knee OA to assess pain, stiffness, and physical function. This questionnaire 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). All questions ask participants to report their level of difficulty performing different tasks, 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. The score is calculated as a percentage of 96. With 100% being the worst and 0% being the best.
- Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: 6 months ]This instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning, and mental health.
- Pain Changes using the Visual Analogue Scale (VAS) [ Time Frame: 6 months ]The VAS is the most common pain scale for quantification of disease related pain.This consists of a horizontal line, 100 mm in length, anchored by word descriptors at each end, "no pain" and "very severe pain" respectively. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks. 100 mm=very severe pain, 0mm=no pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410355
|Canada, Nova Scotia|
|Nova Scotia Health Authority|
|Halifax, Nova Scotia, Canada, B3H 2E1|
|Principal Investigator:||Ivan Wong, MD||Nova Scotia Health Authority|