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

Not Applicable

Terminated

• Conditions: Joint Diseases; Arthritis
• Interventions: Procedure: Suspensionplasty with two-suture construct; Procedure: Suspensionplasty with one-suture construct; Procedure: Ligament reconstruction tendon interposition

• Registration Number: NCT02591368
• Lead Sponsor: Orlando Health, Inc.

Brief 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.

Exclusion Criteria

• To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
• Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
• Patients that are non-operative candidates due to medical comorbidities will also be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini Tight rope with two-suture	Suspensionplasty with two-suture construct	Mini Tight rope with two sutures
Mini Tight rope with one-suture	Suspensionplasty with one-suture construct	Mini Tight rope with one suture
Ligament reconstr. tendon interposition	Ligament reconstruction tendon interposition	Ligament reconstruction, tendon interposition.

Primary Outcome Measures

Name	Time	Method
Pinch/grip strength	An average of 5 years.	the measurable ability to exert pressure with the hand, fingers, or both. It is measured by having a patient forcefully squeeze, grip, or pinch dynamometers; results are expressed in either pounds or kilograms of pressure.
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire	An average of 5 years.	30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity
Patient satisfaction surveys	An average of 5 years.	Patient-reported experiences on care received
SF-36 patient survey scores	On the follow-up visits	Commonly accepted functional outcome scores used to evaluate patients post-operatively

Secondary Outcome Measures

Name	Time	Method
Visual pain scale	An average of 5 years.	Unidimensional measure of pain intensity anchored by scores of 0 \["no pain"\] and 10 \[worst pain imaginable\] at its extremes.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States