Osteoarthritis, HipBMACNCT03410355
Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis
A study testing BMAC/PRP Injection and Cortisone Injection in people with Osteoarthritis, Hip, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- BMAC/PRP Injection and Cortisone Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 17 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Has any pathology of lumbar spine, sacroiliac (SI) joints, neuropathic or extra-articular hip pain
- Has a history of alcohol or drug abuse within the six months prior to enrolment in the study
- Has had a diagnosis of rheumatoid arthritis
- Has had a diagnosis of ankylosing spondylitis
- Has had a diagnosis of psoriatic arthritis
- Has had a diagnosis of reactive arthritis
- Has had a diagnosis of gout
- Has had a diagnosis of any connective tissue disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Bone Marrow Aspirate Concentrate in the Context of Hip Osteoarthritis: A Randomized Controlled Trial
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.
Read the detailed description
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.
Pre-Injection Procedures:
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.
Injection Procedures:
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).
Post-Injection Procedures:
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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- BMAC/PRP Injection, Cortisone Injection
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC/PRP InjectionProcedure or surgery
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.
Cortisone InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| BMAC/PRP Injection Group | Experimental | This group will receive an injection of BMAC/PRP for treatment of OA Receives: Procedure: BMAC/PRP Injection |
| Cortisone Injection Group | Active comparator | This group will receive an injection of cortisone for treatment of OA Receives: Procedure: Cortisone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS)
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.
Measured: 6 months
Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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.
Measured: 6 months
Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12)
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.
Measured: 6 months
Pain Changes using the Visual Analogue Scale (VAS)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Feb 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Why it stopped: Health Canada no longer allowed use of BMAC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Wong, Nova Scotia Health Authority
- Investigators
- Ivan Wong, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410355
- Sponsor's protocol ID
- IW-001
- Acronym
- BMAC
- Status last verified
- Mar 2022
- First submitted
- 22 Dec 2017
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bone Marrow Aspirate Concentrate in the Context of Hip Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03410355
- Acronym / sponsor ID
- BMAC / IW-001
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Health Canada no longer allowed use of BMAC
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Pre-Injection Procedures:
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.
Injection Procedures:
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).
Post-Injection Procedures:
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| BMAC/PRP Injection Group | Experimental | Procedure: BMAC/PRP InjectionThis group will receive an injection of BMAC/PRP for treatment of OA |
| Cortisone Injection Group | Active comparator | Procedure: Cortisone InjectionThis group will receive an injection of cortisone for treatment of OA |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMAC/PRP InjectionPatients 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 or surgery | BMAC/PRP Injection Group |
| Cortisone InjectionAn intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be injected in the hip joint under ultrasound. | Procedure or surgery | Cortisone Injection Group |
Primary outcome
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.
4 secondary outcomes
Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS)
Time frame: 6 months
Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months
Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 6 months
Pain Changes using the Visual Analogue Scale (VAS)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Health Canada no longer allowed use of BMAC). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Wong, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMAC/PRP Injection and Cortisone Injection in people with Osteoarthritis, Hip, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Health Canada no longer allowed use of BMAC). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Benefit and Pain Level Changes using iHOT33 Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.