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Completed

NCT Number: NCT02352610

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H3A7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LRTI

Procedure

Biotenodesis Screw

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. EQ-5D Health Questionnaire Score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

  2. DASH questionnaire score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

  3. Grip strength as measured by dynamometer

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

  4. Pinch strength as measured by dynamometer

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

  5. Opposition as measured by goniometer

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

    thumb range of motion

  6. Radial abduction as measured by goniometer

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

    thumb range of motion

  7. Palmar abduction as measured by goniometer

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

    thumb range of motion

  8. 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

Other outcomes

  1. Number of participants with Adverse Events

    Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Sponsors and collaborators

Lead sponsor

Andrew Trenholm

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2015
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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