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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthritis, Joint Diseases

Intervention / Treatment
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* Procedure: Ligament reconstruction tendon interposition
* Procedure: Suspensionplasty with one-suture construct
* Procedure: Suspensionplasty with two-suture construct


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligament reconstr. tendon interposition<br>Ligament reconstruction, tendon interposition. | Procedure: Ligament reconstruction tendon interposition<br>* 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.<br>|
| Active Comparator: Mini Tight rope with one-suture<br>Mini Tight rope with one suture | Procedure: Suspensionplasty with one-suture construct<br>* 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.<br>|
| Active Comparator: Mini Tight rope with two-suture<br>Mini Tight rope with two sutures | Procedure: Suspensionplasty with two-suture construct<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of Arm, Shoulder & Hand (DASH) questionnaire | 30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity | An average of 5 years. | 
| SF-36 patient survey scores | Commonly accepted functional outcome scores used to evaluate patients post-operatively | On the follow-up visits | 
| Patient satisfaction surveys | Patient-reported experiences on care received | An average of 5 years. | 
| Pinch/grip strength | 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. | An average of 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual pain scale | Unidimensional measure of pain intensity anchored by scores of 0 [no pain] and 10 [worst pain imaginable] at its extremes. | An average of 5 years. |