Clinical Trials Directory

Trials / Completed

CompletedNCT06858800

Pinch Grip and Functional Outcomes Between Hematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis.

Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
96 (actual)
Sponsor
Hospital de la Santa creu i Sant Pau - Barcelona · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.

Conditions

Interventions

TypeNameDescription
PROCEDURELTRI techniqueHematoma distraction Artroplasty (HDA): A dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid. Ligament reconstruction with tendon interposition (LRTI): A complete removal of the trapezium bone with a radial-volar incision was made with posterior resection of the articular surface of the first metacarpal bone, and ligament transfer with a loop from hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint while occupying the space of the resected bone following modified Weilby Garcia-Elias technique
PROCEDUREHDA techniqueA dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid

Timeline

Start date
2017-01-01
Primary completion
2020-01-01
Completion
2021-01-01
First posted
2025-03-05
Last updated
2025-04-16

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06858800. Inclusion in this directory is not an endorsement.