Thumb Carpometacarpal Joint OsteoarthritisNCT04886349
Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis
An observational study of Thumb Carpometacarpal Joint Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate a case series of patients treated with Platelet-rich plasma for thumb carpometacarpal joint osteoarthritis. Carpometacarpal arthritis is a highly prevalent condition with significant effects on quality of life and function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thumb Carpometacarpal Joint Osteoarthritis
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 2 Apr 2021
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those with CMC OA who received PRP injections
Who may be able to join
- Patients who previously underwent PRP injection of their first CMC joint.
Who cannot join
- Individuals less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate a case series of patients treated with Platelet-rich plasma for thumb carpometacarpal joint osteoarthritis. Carpometacarpal arthritis is a highly prevalent condition with significant effects on quality of life and function. Meanwhile, platelet-rich plasma has been demonstrated to be an effective treatment for various musculoskeletal conditions.
Read the 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.
- Being tested
- Platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaBiological
Platelet-rich plasma injection for first CMC OA
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Subjective patient satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best. Obtained via follow-up interview.
Measured: up to 12 months
Patient symptom improvement
Subjective symptom satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best. Obtained via follow-up interview.
Measured: up to 12 months
Visual analogue pain scale
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.
Measured: up to 12 months
Follow-up procedures/surgeries/interventions
Patient described any required procedures/surgeries/interventions
Measured: up 12 months
Biologic characteristics of the whole blood and platelet-rich plasma included platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, and monocytes
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.
Measured: Day of procedure (within 24 hours of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Oct 2020
- Primary completion1 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb Carpometacarpal Joint OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey S. Brault, Mayo Clinic
- Investigators
- Jeffrey Brault, D.O., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886349
- Sponsor's protocol ID
- 20-008912
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT04886349
- Acronym / sponsor ID
- 20-008912
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 14 May 2021 (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 investigate a case series of patients treated with Platelet-rich plasma for thumb carpometacarpal joint osteoarthritis. Carpometacarpal arthritis is a highly prevalent condition with significant effects on quality of life and function. Meanwhile, platelet-rich plasma has been demonstrated to be an effective treatment for various musculoskeletal conditions.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those with CMC OA who received PRP injections
Key inclusion criteria (1 listed)
- Patients who previously underwent PRP injection of their first CMC joint.
Key exclusion criteria (1 listed)
- Individuals less than 18 years of age.
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 |
|---|---|---|
| Platelet-rich plasmaPlatelet-rich plasma injection for first CMC OA | Biological | – |
Primary outcome
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.
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.
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.
Follow-up procedures/surgeries/interventions
Time frame: up 12 months
Patient described any required procedures/surgeries/interventions
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jeffrey Brault, D.O. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Carpometacarpal Joint Osteoarthritis, run by Mayo Clinic 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction (time frame: up to 12 months). The study lists 5 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 14 May 2021.