Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811287
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-03-10
Brief Title:
PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
Sponsor:
Michael Fredericson MD
Organization:
Stanford University
Study Overview
Official Title:
Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study assesses the potential benefit of adjuvant platelet-rich plasma PRP with carpal tunnel release CTR for patients with severe carpal tunnel syndrome CTS CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS but a number of patients with severe CTS do not have quite the same response post-CTR The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery
Detailed Description:
1 Study team recruits patients with severe CTS who meet inclusion and exclusion criteria in an outpatient hand surgery clinic Patients will be consented by the research team if the patient agrees to participate in the research study
2 This will be a single blinded study and participants will have an equal chance to be placed in either group Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP All participants will have a pre-operative electromyographynerve conduction study EMGNCS
3 Primary outcome measures BCTQ and grip strength and secondary outcome measures PROMIS 2 point discrimination - thumb index finger and middle finger key pinch 3 finger pinch and EMGNCS results will be collected and stored in REDCap at initial visit BCTQ and PROMIS will actually be available online for patient to complete at the patients convenience
4 Patients will undergo CTR with or without adjuvant PRP based on assigned study group Patients will not know which group the subject is in single blinded
5 BCTQ and PROMIS will be collected online at 3 months 6 months and 12 months post-operatively EMGNCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic At these visits the investigators will also collect data on 2 point discrimination grip strength key pinch and 3 finger pinch
6 The investigators will store data in REDCap
7 Data will be analyzed with the assistance of our biostatistician and results will be written up
2 This will be a single blinded study and participants will have an equal chance to be placed in either group Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP All participants will have a pre-operative electromyographynerve conduction study EMGNCS
3 Primary outcome measures BCTQ and grip strength and secondary outcome measures PROMIS 2 point discrimination - thumb index finger and middle finger key pinch 3 finger pinch and EMGNCS results will be collected and stored in REDCap at initial visit BCTQ and PROMIS will actually be available online for patient to complete at the patients convenience
4 Patients will undergo CTR with or without adjuvant PRP based on assigned study group Patients will not know which group the subject is in single blinded
5 BCTQ and PROMIS will be collected online at 3 months 6 months and 12 months post-operatively EMGNCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic At these visits the investigators will also collect data on 2 point discrimination grip strength key pinch and 3 finger pinch
6 The investigators will store data in REDCap
7 Data will be analyzed with the assistance of our biostatistician and results will be written up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None