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

NCT07698301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Carpometacarpal (CMC) Joint Arthritis

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.

Sponsors & Collaborators

  • Theodoros Mylonas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698301 on ClinicalTrials.gov