NCT02591368

MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis

MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.

Detailed description

The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder \& Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications.

Conditions

• Arthritis
• Joint Diseases

Interventions

Type	Name	Description
PROCEDURE	Ligament reconstruction tendon interposition	In this procedure the trapezium is removed and one of the patient's own tendons (or portion of the tendon), usually the flexor carpi radialis or abductor pollicis longus, is passed through a drill hole in the thumb metacarpal and is used to suspend the first metacarpal base.
PROCEDURE	Suspensionplasty with one-suture construct	In this procedure the trapezium is removed and an Arthrex mini tightrope system using Fiberwire suture is drilled across the first metacarpal to the second metacarpal and is used to suspend the first metacarpal base instead of a tendon.
PROCEDURE	Suspensionplasty with two-suture construct	In this procedure the trapezium is removed and two Arthrex mini tightrope systems using Fiberwire sutures are drilled across the first metacarpal to the second metacarpal and are used to suspend the first metacarpal base instead of a tendon.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-10-29
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States