Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290986
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-14
Brief Title:
Pyrocardan Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis
Sponsor:
Herlev and Gentofte Hospital
Organization:
Herlev and Gentofte Hospital
Study Overview
Official Title:
Pyrocardan Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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 is a randomized controlled trial comparing the Pyrocardan implant intervention group with the standard ligament reconstruction and tendon interposition LRTI control group All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in HerlevGentofte will be considered for participation in the trial The following exclude from participation in the study Below 40 years of age cognitive or linguistic impairment osteoarthritis of other carpal bones previous surgery in the carpometacarpal joint patients with rheumatoid arthritis A total of 64 patients will be included The primary outcome is the patient reported outcomes questionnaire Quick-DASH The secondary outcomes are patient-reported outcomes functional outcomes radiographic outcomes readmission complications revisions The patients are examined before surgery and 3 6 12 and 24 months after the operation The patients are also contacted after 5 and 10 years
Detailed Description:
The Pyrocardan is designed by Philippe Bellemere and has been used since 2009 It is a biconcave-shaped CMC-1 interposition implant The biconcave shape converts the CMC-1 saddle joint into a cardan-like joint The implant is suitable for Eaton grade 2 or 3 The advantages compared to LRTI are believed to be preserved thumb length faster recovery following surgery increased grip and pinch strengths and less subsidence of the CMC-1 joint
Most recently results from the Bellemere group in 2020 have shown excellent results in 103 patients 5 years following surgery A study by Gerace et al reported a significant improvement in pain QuickDASH and strength with a revision rate of 4 and a survival rate at 96 at 5 years of follow-up A recent review from 2022 reported 97 survival rate at 4 years and an estimated survival rate of 95 at 7 years from surgery
The purpose of this randomized study is to compare Pyrocardan implant intervention group 1 with ligament reconstruction and tendon interposition LRTI intervention group 2 in patients treated with mild to moderate CMC-1 osteoarthritis There is to our knowledge no randomized controlled trial RCT studies on Pyrocardan implant
Hypothesis Pyrocardan can provide a faster recovery following surgery increased grip and pinch strengths and less subsidence of the CMC-1 joint compared to LRTI
All patients referred to the Orthopedic Surgery Department Hand Surgery Unit at Copenhagen University Hospital in HerlevGentofte with CMC-1 OA with pain in the thumb base and suspected degenerative changes and indication of surgical treatment will be eligible for inclusion The following criteria will result in exclusion from participation in the study Age under 40 cognitive or linguistic impairment presence of osteoarthritis in other carpal bones previous surgery in trapeziometacarpal joint or diagnosis of rheumatoid arthritis
A total of 64 patients will be included in the study based on a sample size calculation using the MCID of Q-DASH This number will also account for a maximum dropout rate of 18 The study will be a randomized clinical trial RCT where participants will be assigned to one of the two surgical techniques through a randomized process Patients will be monitored to evaluate any differences between the techniques The primary outcome measure will be the patient-reported outcome using the QuickDASH assessment Secondary outcomes will include pain relief questionnaires radiographic changes range of motion and strength functional outcome readmission rates complications and revisions Patients will undergo examinations before the surgery and at 6 weeks 3 months 6 months 12 months and 24 months after the surgery Additionally patients will be contacted 5 and 10 years following the surgery for further follow-up The study will be conducted as a single-center study and all procedures will be performed by one of three experienced hand surgeons
Most recently results from the Bellemere group in 2020 have shown excellent results in 103 patients 5 years following surgery A study by Gerace et al reported a significant improvement in pain QuickDASH and strength with a revision rate of 4 and a survival rate at 96 at 5 years of follow-up A recent review from 2022 reported 97 survival rate at 4 years and an estimated survival rate of 95 at 7 years from surgery
The purpose of this randomized study is to compare Pyrocardan implant intervention group 1 with ligament reconstruction and tendon interposition LRTI intervention group 2 in patients treated with mild to moderate CMC-1 osteoarthritis There is to our knowledge no randomized controlled trial RCT studies on Pyrocardan implant
Hypothesis Pyrocardan can provide a faster recovery following surgery increased grip and pinch strengths and less subsidence of the CMC-1 joint compared to LRTI
All patients referred to the Orthopedic Surgery Department Hand Surgery Unit at Copenhagen University Hospital in HerlevGentofte with CMC-1 OA with pain in the thumb base and suspected degenerative changes and indication of surgical treatment will be eligible for inclusion The following criteria will result in exclusion from participation in the study Age under 40 cognitive or linguistic impairment presence of osteoarthritis in other carpal bones previous surgery in trapeziometacarpal joint or diagnosis of rheumatoid arthritis
A total of 64 patients will be included in the study based on a sample size calculation using the MCID of Q-DASH This number will also account for a maximum dropout rate of 18 The study will be a randomized clinical trial RCT where participants will be assigned to one of the two surgical techniques through a randomized process Patients will be monitored to evaluate any differences between the techniques The primary outcome measure will be the patient-reported outcome using the QuickDASH assessment Secondary outcomes will include pain relief questionnaires radiographic changes range of motion and strength functional outcome readmission rates complications and revisions Patients will undergo examinations before the surgery and at 6 weeks 3 months 6 months 12 months and 24 months after the surgery Additionally patients will be contacted 5 and 10 years following the surgery for further follow-up The study will be conducted as a single-center study and all procedures will be performed by one of three experienced hand surgeons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None