A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study

July 16, 2018 updated by: Andrew Trenholm
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation.

The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Queen Elizabeth II Health Sciences Centre

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First CMC primary osteoarthritis refractory to conservative treatment
  • Patient >age 18
  • Able to read and understand English
  • Available for 2 year follow up

Exclusion Criteria:

  • Inflammatory Arthritis
  • Active infection in the first CMC joint
  • Concomitant neuropathy
  • Previous surgical procedure on the thumb
  • Active or status post CRPS
  • Severe ¨Z ¨deformity that requires palmar plate advancement
  • Unwilling to participate in a research project
  • Contralateral first CMC joint surgery

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LRTI without a Biotenodesis Screw
Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw
Procedure: LRTI
Active Comparator: LRTI with Biotenodesis Screw
Ligament Reconstruction Tendon Interposition with Biotenodesis Screw
Procedure: LRTI
Device: Biotenodesis Screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsidence of CMC joint
Time Frame: 6 weeks, 3 months, 6 months, 1 year, 2 years
Measurement of trapezial height as a percentage of pre-operative height
6 weeks, 3 months, 6 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D Health Questionnaire Score
Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
DASH questionnaire score
Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength as measured by dynamometer
Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years
Baseline, 3 months, 6 months, 1 year, 2 years
Pinch strength as measured by dynamometer
Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years
Baseline, 3 months, 6 months, 1 year, 2 years
Opposition as measured by goniometer
Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Baseline, 3 months, 6 months, 1 year, 2 years
Radial abduction as measured by goniometer
Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Baseline, 3 months, 6 months, 1 year, 2 years
Palmar abduction as measured by goniometer
Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Baseline, 3 months, 6 months, 1 year, 2 years
Pain score on the visual analogue scale
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
visual analogue scale
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

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

Sponsor

Andrew Trenholm

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

March 1, 2015

Primary Completion (Actual)

February 22, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-239

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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