- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886349
Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The first carpometacarpal (CMC) joint at the base of the thumb is one of the most commonly affected joints by osteoarthritis (OA), with a prevalence ranging from 15-36% in females and 5-11% in males. It is also functionally debilitating, with symptoms including diminished range of motion, weakness, deformity, instability, and pain. Despite the prevalence of first CMC OA, as well as the emerging evidence of platelet-rich plasma (PRP) efficacy for various musculoskeletal conditions, there is a paucity of studies investigating the two. To our knowledge, there are three studies in the literature, resulting in a total of 27 patients with first CMC OA receiving PRP to date1.
Common nonsurgical treatment options for management of this condition include oral and topical NSAIDs, hand therapy, activity modifications, splinting and intra-articular injections. Injections have traditionally consisted of corticosteroids demonstrating variable efficacy and viscosupplementation resulting in conflicting results. Surgical options include trapeziectomy with ligament reconstruction and tendon interposition, fusion, and less commonly, implant arthroplasty.
PRP is defined as an autologous, concentrated mix of platelets and inflammatory mediators suspended in plasma, obtained by centrifuging a patient's whole blood. It is hypothesized that PRP stimulates recruitment, proliferation, and differentiation of regenerative cells via release of various growth factors such as platelet-derived growth factor-AB and -BB, transforming growth factor-β1, insulin-like growth factor-1, fibroblast growth factor-basic, epidermal growth factor, vascular endothelial growth factor, and interleukin (IL)-12. The platelets in PRP have anti-inflammatory properties with modulators including IL-1 receptor antagonist, soluble tumor necrosis factor receptor I and II, IL-4, IL-10, IL-13 and interferon γ. Although PRP has been used for numerous musculoskeletal conditions, varying methods of extraction, different types of PRP, and lack of standardized reporting on the detailed biologic makeup of PRP has caused difficulties with interpretation and comparison of studies investigating its use. For these reasons, there has been a call for the standardization of PRP in clinical use.
The primary aim of this study was to assess (1) outcomes of PRP injection among patients with first CMC OA, and (2) the biologic characteristics of PRP injectate. The secondary aims were to describe the injection technique used at our institution and analyze the relationships between patient demographics, PRP biologic characteristics, and patient outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who previously underwent PRP injection of their first CMC joint.
Exclusion Criteria:
- Individuals less than 18 years of age.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: up to 12 months
|
Subjective patient satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best.
Obtained via follow-up interview.
|
up to 12 months
|
Patient symptom improvement
Time Frame: up to 12 months
|
Subjective symptom satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best.
Obtained via follow-up interview.
|
up to 12 months
|
Visual analogue pain scale
Time Frame: up to 12 months
|
Subjective pain rating on a scale of 1-10 with 1 being no pain and 10 being severe pain.
Obtained via automatically-generated follow-up questionnaire through electronic medical record.
Obtained via follow-up interview.
|
up to 12 months
|
Follow-up procedures/surgeries/interventions
Time Frame: up 12 months
|
Patient described any required procedures/surgeries/interventions
|
up 12 months
|
Biologic characteristics of the whole blood and platelet-rich plasma included platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, and monocytes
Time Frame: Day of procedure (within 24 hours of procedure)
|
Platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, and monocytes were measured in whole blood and platelet-rich plasma.
These were reported in concentration of 10^9/milliliter.
There is little data regarding these expected values of platelet rich plasma and these are known to vary widely.
Obtained through quality control analysis which was sent to pathology lab the day of procedure.
|
Day of procedure (within 24 hours of procedure)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Brault, D.O., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-008912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thumb Carpometacarpal Joint Osteoarthritis
-
University of MinnesotaRecruitingThumb Carpometacarpal Osteoarthritis | Thumb Basal Joint OsteoarthritisUnited States
-
Indiana Hand to Shoulder CenterCTM BiomedicalEnrolling by invitationOsteoarthritis | Osteoarthritis Thumb Base Joint | Carpometacarpal Osteoarthritis | ThumbUnited States
-
Mayo ClinicTerminatedThumb Carpometacarpal Joint OsteoarthritisUnited States
-
University of AlbertaRecruitingThumb Osteoarthritis | Osteoarthritis of the Carpometacarpal JointCanada
-
Medical University of WarsawNot yet recruitingThumb Osteoarthritis | Rhizarthrosis | Carpometacarpal OsteoarthritisPoland
-
Washington University School of MedicineActive, not recruiting
-
IsalaUnknownTrapeziometacarpal Osteoarthritis | Thumb Carpometacarpal OsteoarthritisNetherlands
-
IsalaUnknownTrapeziometacarpal Osteoarthritis | Thumb Carpometacarpal OsteoarthritisNetherlands
-
Brent DeGeorgeNot yet recruitingArthritis of Carpometacarpal Joint of Left Thumb | Arthritis of Carpometacarpal Joint of Right Thumb
-
Schulthess KlinikCompletedJoint Instability | Osteoarthritis Thumb | Arthrosis of First Carpometacarpal JointSwitzerland
Clinical Trials on Platelet-rich plasma
-
Stanford UniversityPartnership for Clean CompetitionCompletedRheumatic Diseases | TendinopathyUnited States
-
VivaTech International, Inc.RecruitingOsteoarthritisUnited States
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingMenopause, Premature | Menopausal Syndrome | Premature Ovarian Failure | Ovarian Failure, Premature | Menopause Related ConditionsGreece
-
Cardenal Herrera UniversityCompletedCarpal Tunnel SyndromeSpain
-
Damascus UniversityCompletedBone ResorptionSyrian Arab Republic
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
Peking University Third HospitalRecruiting
-
Matthew GettmanCompleted
-
Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
EgymedicalpediaAl-Azhar UniversityCompletedUrinary Incontinence | Stress Urinary IncontinenceEgypt