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

July 7, 2026 updated by: Theodoros Mylonas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41500
        • University Hospital of Larissa, Thessaly, Greece

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic thumb carpometacarpal osteoarthritis
  • Eaton-Littler stage II-IV
  • Failure of at least six months of conservative treatment
  • Ability to provide informed consent
  • Ability to comply with follow-up

Exclusion Criteria

  • Inflammatory arthritis
  • Previous thumb surgery
  • Concomitant carpal pathology
  • Incomplete radiographs
  • Inability to comply with rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mini TightRope Suspensionplasty
Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system.
Procedure: Mini tightrope suspensionplasty
Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system
Active Comparator: Ligament Reconstruction and Tendon Interposition (LRTI)
Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition.
Procedure: Ligament Reconstruction and Tendon Interposition (LRTI)
Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quick DASH score
Time Frame: 2 years
Quick Disabilities of the Arm, Shoulder and Hand score measured preoperatively and during follow-up, with the primary endpoint at two years.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 2 years
Visual Analog Scale pain score
2 years
Kapandji score
Time Frame: 2 years
Kapandji thumb opposition score
2 years
Grip strength
Time Frame: 2 years
Grip strength using a dynamometer
2 years
Trapeziometacarpal Index
Time Frame: 2 years
the ratio between the distance from the base of the first metacarpal to the distal surface of the scaphoid and the total length of the first metacarpal
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodoros Mylonas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52432/02-01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpometacarpal (CMC) Joint Arthritis

Clinical Trials on Mini tightrope suspensionplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe