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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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

LRTI

Biotenodesis Screw

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring carpometacarpal joints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Queen Elizabeth II Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LRTI without a Biotenodesis Screw

LRTI with Biotenodesis Screw

Arm Description

Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw

Ligament Reconstruction Tendon Interposition with Biotenodesis Screw

Outcomes

Primary Outcome Measures

Subsidence of CMC joint

Measurement of trapezial height as a percentage of pre-operative height

Secondary Outcome Measures

EQ-5D Health Questionnaire Score

DASH questionnaire score

Grip strength as measured by dynamometer

Pinch strength as measured by dynamometer

Opposition as measured by goniometer

thumb range of motion

Radial abduction as measured by goniometer

thumb range of motion

Palmar abduction as measured by goniometer

thumb range of motion

Pain score on the visual analogue scale

visual analogue scale

Full Information

NCT ID

NCT02352610

First Posted

January 8, 2015

Last Updated

July 16, 2018

Sponsor

Andrew Trenholm

1. Study Identification

Unique Protocol Identification Number

NCT02352610

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

February 22, 2018 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew Trenholm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

carpometacarpal joints

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LRTI without a Biotenodesis Screw

Arm Type

Active Comparator

Arm Description

Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw

Arm Title

LRTI with Biotenodesis Screw

Arm Type

Active Comparator

Arm Description

Ligament Reconstruction Tendon Interposition with Biotenodesis Screw

Intervention Type

Procedure

Intervention Name(s)

LRTI

Intervention Type

Device

Intervention Name(s)

Biotenodesis Screw

Primary Outcome Measure Information:

Title

Subsidence of CMC joint

Description

Measurement of trapezial height as a percentage of pre-operative height

Time Frame

6 weeks, 3 months, 6 months, 1 year, 2 years

Secondary Outcome Measure Information:

Title

EQ-5D Health Questionnaire Score

Time Frame

Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

DASH questionnaire score

Time Frame

Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

Grip strength as measured by dynamometer

Time Frame