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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07698301
Enrollment
50
Registered
2026-07-13
Start date
2020-01-01
Completion date
2025-12-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpometacarpal (CMC) Joint Arthritis

Keywords

CMC arthritis, mini tightrope, tendon interposition, trapeziectomy

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.

Interventions

PROCEDUREMini tightrope suspensionplasty

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

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

Sponsors

Theodoros Mylonas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
quick DASH score2 yearsQuick Disabilities of the Arm, Shoulder and Hand score measured preoperatively and during follow-up, with the primary endpoint at two years.

Secondary

MeasureTime frameDescription
VAS score2 yearsVisual Analog Scale pain score
Kapandji score2 yearsKapandji thumb opposition score
Grip strength2 yearsGrip strength using a dynamometer
Trapeziometacarpal Index2 yearsthe 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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026