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

March 2, 2020 updated by: Brett Lewellyn, Orlando Health, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ligament reconstr. tendon interposition
Ligament reconstruction, tendon interposition.
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.
Active Comparator: Mini Tight rope with one-suture
Mini Tight rope with one suture
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.
Active Comparator: Mini Tight rope with two-suture
Mini Tight rope with two sutures
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
Time Frame: An average of 5 years.
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
Time Frame: On the follow-up visits
Commonly accepted functional outcome scores used to evaluate patients post-operatively
On the follow-up visits
Patient satisfaction surveys
Time Frame: An average of 5 years.
Patient-reported experiences on care received
An average of 5 years.
Pinch/grip strength
Time Frame: 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.
An average of 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual pain scale
Time Frame: 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.
An average of 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Health, Inc.

Investigators

  • Principal Investigator: Brett Lewellyn, MD, Orlando Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.035.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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