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NCT01121874 · ClinicalTrials.gov registry record · NA
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
A NA study of Thumb Carpometacarpal Arthritis, sponsored by J&M Shuler.
- Completed
- Registry status
- NA
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT01121874: Completed NA study of Thumb Carpometacarpal Arthritis, sponsored by J&M Shuler.
NCT01121874 is a NA study of Thumb Carpometacarpal Arthritis that has completed, run by J&M Shuler. The registered enrollment target is 53 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121874, a NA study of Thumb Carpometacarpal Arthritis, has completed, sponsored by J&M Shuler.
- COMPLETED
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist. We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
Primary Outcome
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
Conditions Studied
Interventions
- PROCEDURE Ligament reconstruction with suture fixation system
- PROCEDURE Ligament Reconstruction with Tendon Interposition (LRTI)
Study Locations (1)
Georgia
- Athens Orthopedic Clinic - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2010-04-12 |
| Est. Completion | 2012-07-25 |
| Phase | NA |
What the finished NCT01121874 record still lists
NCT01121874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Thumb Carpometacarpal Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Ligament reconstruction with suture fixation system is the first listed.
NCT01121874 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01121874 about?
NCT01121874 is a clinical study titled "Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty". Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interpositi...
What is the current status of trial NCT01121874?
This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2010-04-12. Estimated completion is 2012-07-25.
What conditions does trial NCT01121874 study?
This clinical trial studies the following conditions: Thumb Carpometacarpal Arthritis.
What interventions are being tested in trial NCT01121874?
The interventions under investigation include: Ligament reconstruction with suture fixation system (PROCEDURE), Ligament Reconstruction with Tendon Interposition (LRTI) (PROCEDURE).
Who is sponsoring clinical trial NCT01121874?
This trial is sponsored by J&M Shuler, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01121874 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01121874's enrollment target sits among peer trials
53 1271st of 2000 higher than 729 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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