Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis

NCT04886349 | Completed

• 1 other identifier: 20-008912
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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. Meanwhile, platelet-rich plasma has been demonstrated to be an effective treatment for various musculoskeletal conditions.

Conditions

Thumb Carpometacarpal Joint Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  up to 12 months

• Follow-up procedures/surgeries/interventions

  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

  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)

Interventions

Platelet-rich plasma BIOLOGICAL

Platelet-rich plasma injection for first CMC OA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those with CMC OA who received PRP injections

You may qualify if:

• \- Patients who previously underwent PRP injection of their first CMC joint.

You may not qualify if:

• \- Individuals less than 18 years of age.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jeffrey Brault, D.O.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 14, 2021
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 2, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)