Osteoarthritis, HipPhase 1NCT04241354
A Comparison of PRP Treatment to the IA vs. IA and EA Environments in Patients Diagnosed With Hip Osteoarthritis
A Phase 1 study testing Leukocyte-poor platelet rich plasma in people with Osteoarthritis, Hip and Osteoarthritis, run by Regenerative Orthopedics and Sports Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of one leukocyte-poor platelet-rich plasma (LP-PRP) injection to the intra-articular (IA) space in comparison to one LP-PRP injection to the IA space with an additional injection into the surrounding extra-articular (EA) structures for the treatment of hip OA… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Degeneration
- What is being tested?
- Leukocyte-poor platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 25 Aug 2022
- Phase
- Phase 1
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic OA of hip (K-L Grade 1-3) documented by x-ray taken within the past 6 months
- Male or female age 30 - 65 at time of enrollment
- Patients must have adequate immune system function with no known immunodeficiency
- disease
- Has not had a corticosteroid injection in the past 6 months
- Has not used non-steroidal anti-inflammatory 7 days prior to treatment and has not used oral
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- corticosteroids 30 days prior to treatment
- If on chronic anticoagulant medication, we will follow the recommendations of the physician
- managing their anticoagulant medication
- Willing and able to participate for the entire study period
- No evidence of current systemic infection or illness (eg. fever, malaise, etc.) and no evidence
- of skin infection in the areas where the injection will be performed
Who cannot join
- Patients have been diagnosed with an autoimmune disease, diabetes, rheumatoid arthritis,
- hematologic conditions predisposing to bleeding disorders or platelet dysfunction, Paget's disease of femur or ilium, avascular necrosis (AVN) of the femoral head, infectious arthritis, Lyme disease.
- Previous reparative cellular/ orthobiologics /PRP injection
- ≥7mm hip effusion as measured on ultrasound at the femoral neck
- K-L Grade 4 OA x-ray documented
- Patient has a history of alcohol or drug abuse within the six months prior to enrolment in the study
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- Patients who had intra-articular treatment with corticosteroids within 6 months of randomization in this study
- Patient received more than 2 previous intra- or extra-articular corticosteroid injections to the affected hip.
- Patients who are pregnant or nursing at the time of consent
- Patients who have had anorexia, chronic insomnia, immunocompromised state, and/ or are on immunosuppressive medication
- Neoplastic cancer within 5 years prior to screening and no evidence of recurrence, except for cutaneous (basal cell and squamous cell) cancer treated with excision
- History of chemotherapy within the past 3 years or radiation therapy to the involved hip area
- Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
- Patients who have had previous intervention to the hip except for labral repair/ reconstruction and/ or femoral neck osteoplasty or acetabular osteoplasty without microfracture.
- Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
- Use of NSAID 7 days prior to treatment or oral or subcutaneous corticosteroids 30 days prior
- Patients with a BMI over 35
- Deformity or dysplasia (i.e. Legg Calve Perthes or DDH) other than FAI.
- Patients with systemic infection, hematological conditions, malignancy, blood borne diseases, allergies to lidocaine.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Regenerative Orthopedics and Sports Medicine
North Bethesda, Maryland, 20852
Wesley McClure, BA, 301-906-8294, research@rosm.org
Sean W Mulvaney, MD
About this study
Official title: A Comparison of Platelet-rich Plasma Treatment to the Intra-articular vs. Intra- and Extra-articular Environments in Patients Diagnosed With Hip Osteoarthritis
The purpose of this study is to evaluate the efficacy of one leukocyte-poor platelet-rich plasma (LP-PRP) injection to the intra-articular (IA) space in comparison to one LP-PRP injection to the IA space with an additional injection into the surrounding extra-articular (EA) structures for the treatment of hip OA (Kellgren Lawrence Grades 1-3). Our hypothesis is that patients receiving both IA and EA LP-PRP injections will have equivalent improvements on HOOS JR and VAS scores over a 12-month period compared to those in the active comparator group (IA LP-PRP injection).
Read the detailed description
A novel comprehensive approach through which the joint and its surrounding structures are treated as an integrated system may offer a clinically superior treatment to hip osteoarthritis (OA) compared to only an intra-articular (IA) infiltration. The efficacy of autologous leukocyte-poor platelet-rich plasma (LP-PRP) for the treatment of OA is a growing area of regenerative orthopedic research.
The purpose of this study is to determine if a LP-PRP treatment to both the IA space and EA supporting capsular ligament and tendon structures provides a significant clinical benefit when compared to an IA treatment alone. In this clinical study of 84 patients, both study arms receive effective treatments that are supported by sound medical evidence, making this an ethically strong model to address our hypothesis.
This is a multi-site, randomized, comparative study of LP-PRP treatment into the IA space versus the IA space and EA hip structures. This study is sponsored by Regenerative Orthopedics and Sports Medicine (ROSM) and EmCyte Corporation. Patients who meet the study criteria with at least mild pain as indicated by >25/100 on a 100mm visual analogue scale (VAS) (Sanchez et al. 2011), or <80/100 on HOOS JR with radiographic evidence of Kellgren-Lawrence grades 1-3 hip OA will be invited to participate in this study.
The preparation of PRP is a simple tissue fractionation using centrifugation with EmCyte PurePRP Supraphysiologic SP kit [EmCyte Corp. Fort Myers FL]. Platelet quantification analysis is performed using the Horiba ABX Micros ES 60 [Plymouth Medical]. Primary outcome measures are indicated by overall hip pain severity by HOOS JR and VAS patient reported outcome measures.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Degeneration
- Being tested
- Leukocyte-poor platelet rich plasma
- Keywords
- platelet-rich plasma, leukocyte poor platelet rich plasma, PRP, hip osteoarthritis, osteoarthritis, Regenerative orthopedics and sports medicine, ROSM, EmCyte
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte-poor platelet rich plasmaBiological
Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL].
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular LP-PRP Injection | Active comparator | A single injection of leukocyte poor platelet rich plasma (LP-PRP) will be administered to the intra-articular space under ultrasound guidance at the treatment visit. Receives: Biological: Leukocyte-poor platelet rich plasma |
| Intra- and extra- articular LP-PRP Injection | Experimental | A single injection of LP-PRP will be administered to the intra- articular space and the extra- articular structures under ultrasound guidance at the first visit. Receives: Biological: Leukocyte-poor platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Measured: baseline
Numeric Rating Scale
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Measured: baseline
Numeric Rating Scale
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Measured: 6 weeks
Numeric Rating Scale
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Measured: 4 months
Numeric Rating Scale
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Measured: 6 months
Numeric Rating Scale
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Measured: 12 months
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Measured: 6 weeks
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Measured: 4 months
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Measured: 6 months
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start25 Aug 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion25 Aug 2022 (estimated)
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regenerative Orthopedics and Sports Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EmCyte Corporation
- Responsible party
- Sponsor
- Investigators
- Sean W Mulvaney, MD, Principal investigator, Regenerative Orthopedics and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241354
- Sponsor's protocol ID
- ROSM-HO-001
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Platelet-rich Plasma Treatment to the Intra-articular vs. Intra- and Extra-articular Environments in Patients Diagnosed With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT04241354
- Acronym / sponsor ID
- ROSM-HO-001
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Degeneration
- Keywords
- platelet-rich plasma, leukocyte poor platelet rich plasma, PRP, hip osteoarthritis, osteoarthritis, Regenerative orthopedics and sports medicine, ROSM, EmCyte
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Regenerative Orthopedics and Sports MedicineIndustry (pharma, biotech, devices)
- Collaborators
- EmCyte Corporation
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 25 Aug 2022 (estimated)
- First posted
- 27 Jan 2020 (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 efficacy of one leukocyte-poor platelet-rich plasma (LP-PRP) injection to the intra-articular (IA) space in comparison to one LP-PRP injection to the IA space with an additional injection into the surrounding extra-articular (EA) structures for the treatment of hip OA (Kellgren Lawrence Grades 1-3). Our hypothesis is that patients receiving both IA and EA LP-PRP injections will have equivalent improvements on HOOS JR and VAS scores over a 12-month period compared to those in the active comparator group (IA LP-PRP injection).
Detailed description
A novel comprehensive approach through which the joint and its surrounding structures are treated as an integrated system may offer a clinically superior treatment to hip osteoarthritis (OA) compared to only an intra-articular (IA) infiltration. The efficacy of autologous leukocyte-poor platelet-rich plasma (LP-PRP) for the treatment of OA is a growing area of regenerative orthopedic research.
The purpose of this study is to determine if a LP-PRP treatment to both the IA space and EA supporting capsular ligament and tendon structures provides a significant clinical benefit when compared to an IA treatment alone. In this clinical study of 84 patients, both study arms receive effective treatments that are supported by sound medical evidence, making this an ethically strong model to address our hypothesis.
This is a multi-site, randomized, comparative study of LP-PRP treatment into the IA space versus the IA space and EA hip structures. This study is sponsored by Regenerative Orthopedics and Sports Medicine (ROSM) and EmCyte Corporation. Patients who meet the study criteria with at least mild pain as indicated by >25/100 on a 100mm visual analogue scale (VAS) (Sanchez et al. 2011), or <80/100 on HOOS JR with radiographic evidence of Kellgren-Lawrence grades 1-3 hip OA will be invited to participate in this study.
The preparation of PRP is a simple tissue fractionation using centrifugation with EmCyte PurePRP Supraphysiologic SP kit [EmCyte Corp. Fort Myers FL]. Platelet quantification analysis is performed using the Horiba ABX Micros ES 60 [Plymouth Medical]. Primary outcome measures are indicated by overall hip pain severity by HOOS JR and VAS patient reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular LP-PRP Injection | Active comparator | Biological: Leukocyte-poor platelet rich plasmaA single injection of leukocyte poor platelet rich plasma (LP-PRP) will be administered to the intra-articular space under ultrasound guidance at the treatment visit. |
| Intra- and extra- articular LP-PRP Injection | Experimental | Biological: Leukocyte-poor platelet rich plasmaA single injection of LP-PRP will be administered to the intra- articular space and the extra- articular structures under ultrasound guidance at the first visit. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Symptomatic OA of hip (K-L Grade 1-3) documented by x-ray taken within the past 6 months
- Male or female age 30 - 65 at time of enrollment
- Patients must have adequate immune system function with no known immunodeficiency
- disease
- Has not had a corticosteroid injection in the past 6 months
Key exclusion criteria (19 listed)
- Patients have been diagnosed with an autoimmune disease, diabetes, rheumatoid arthritis,
- hematologic conditions predisposing to bleeding disorders or platelet dysfunction, Paget's disease of femur or ilium, avascular necrosis (AVN) of the femoral head, infectious arthritis, Lyme disease.
- Previous reparative cellular/ orthobiologics /PRP injection
- ≥7mm hip effusion as measured on ultrasound at the femoral neck
- K-L Grade 4 OA x-ray documented
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 |
|---|---|---|
| Leukocyte-poor platelet rich plasmaPlatelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL]. | Biological | Intra- and extra- articular LP-PRP Injection, Intra-articular LP-PRP Injection |
Primary outcome
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: baseline
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Numeric Rating Scale
Time frame: baseline
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Numeric Rating Scale
Time frame: 6 weeks
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Numeric Rating Scale
Time frame: 4 months
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Numeric Rating Scale
Time frame: 6 months
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Numeric Rating Scale
Time frame: 12 months
This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: 6 weeks
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: 4 months
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: 6 months
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: 12 months
This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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.
Sean W Mulvaney, MD principal investigator
Regenerative Orthopedics and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leukocyte-poor platelet rich plasma in people with Osteoarthritis, Hip and Osteoarthritis, run by Regenerative Orthopedics and Sports Medicine at 1 site in United States.
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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wesley McClure, BA (1-(301)-906-8294, Research@rosm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) (time frame: baseline). The study lists 10 primary outcomes in all. 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 9 Sep 2021.