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COMPLETED
NCT07698301
NA

Mini TightRope Suspensionplasty Versus Ligament Reconstruction and Tendon Interposition for Thumb Carpometacarpal Osteoarthritis

Sponsor: Theodoros Mylonas

View on ClinicalTrials.gov

Summary

Thumb carpometacarpal osteoarthritis is a common cause of pain, weakness and functional disability. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is considered a standard surgical procedure, whereas Mini TightRope suspensionplasty has been introduced to facilitate earlier mobilization while maintaining first metacarpal stability. This prospective randomized single-center clinical trial compares Mini TightRope suspensionplasty with LRTI in patients with symptomatic Eaton-Littler stage II-IV thumb carpometacarpal osteoarthritis. Fifty patients were randomized in a 1:1 ratio to undergo either Mini TightRope suspensionplasty or LRTI. Clinical and radiographic outcomes were evaluated preoperatively and at 3 months, 6 months, 1 year and 2 years postoperatively. The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score at 2 years. Secondary outcomes included pain, thumb opposition, grip strength, pinch strength, operative time, radiographic preservation of metacarpal height and complications.

Official title: A Prospective Randomized Clinical Trial Comparing Mini TightRope Suspensionplasty With Ligament Reconstruction and Tendon Interposition (LRTI) for the Surgical Treatment of Thumb Carpometacarpal Osteoarthritis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2020-01-01

Completion Date

2025-12-01

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

PROCEDURE

Mini tightrope suspensionplasty

Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system

PROCEDURE

Ligament Reconstruction and Tendon Interposition (LRTI)

Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition.

Locations (1)

University Hospital of Larissa, Thessaly, Greece

Larissa, Thessaly, Greece