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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

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ClinicalTrials.gov Identifier: NCT02352610
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Trenholm, Nova Scotia Health Authority

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: LRTI Device: Biotenodesis Screw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : February 22, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Number of participants with Adverse Events [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352610


Locations
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Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H3A7
Sponsors and Collaborators
Andrew Trenholm
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Responsible Party: Andrew Trenholm, Orthopaedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02352610    
Other Study ID Numbers: 2015-239
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Keywords provided by Andrew Trenholm, Nova Scotia Health Authority:
carpometacarpal joints
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases