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NCT Number: NCT07698301

Mini TightRope Suspensionplasty Versus Ligament Reconstruction and Tendon Interposition for 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.

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Key information

Conditions

Carpometacarpal (CMC) Joint Arthritis Capillary Malformations, Congenital, 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larissa, Thessaly, Greece

Larissa, Thessaly, 41500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini tightrope suspensionplasty

Procedure

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

Ligament Reconstruction and Tendon Interposition (LRTI)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. VAS score

    Time frame: 2 years

    Visual Analog Scale pain score

  2. Kapandji score

    Time frame: 2 years

    Kapandji thumb opposition score

  3. Grip strength

    Time frame: 2 years

    Grip strength using a dynamometer

  4. 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

Sponsors and collaborators

Lead sponsor

Theodoros Mylonas

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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