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

NCT07698301 | Completed

• 1 other identifier: 52432/02-01-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CMC arthritis; mini tightrope; tendon interposition; trapeziectomy

Outcome Measures

Primary Outcomes (1)

• quick DASH score

  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 Outcomes (4)

• VAS score

  2 years

• Kapandji score

  2 years

• Grip strength

  2 years

• Trapeziometacarpal Index

  2 years

Study Arms (2)

Mini TightRope Suspensionplasty

EXPERIMENTAL

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

Procedure: Mini tightrope suspensionplasty

Ligament Reconstruction and Tendon Interposition (LRTI)

ACTIVE COMPARATOR

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

Procedure: Ligament Reconstruction and Tendon Interposition (LRTI)

Interventions

Mini tightrope suspensionplasty PROCEDURE

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

Mini TightRope Suspensionplasty

Ligament Reconstruction and Tendon Interposition (LRTI) PROCEDURE

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

Ligament Reconstruction and Tendon Interposition (LRTI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Theodoros Mylonas: lead

Study Sites (1)

University Hospital of Larissa, Thessaly, Greece

Larissa, Thessaly, 41500, Greece

Location

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of Orthopaedics

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 13, 2026

Record last verified: 2025-12

Locations

GR (1)