Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date July 17, 2018
Study Start Date  ICMJE March 2015
Actual Primary Completion Date February 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • EQ-5D Health Questionnaire Score [ Time Frame: 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 ]
  • Grip strength as measured by dynamometer [ Time Frame: 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 ]
  • Opposition as measured by goniometer [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ]
    thumb range of motion
  • Radial abduction as measured by goniometer [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ]
    thumb range of motion
  • Palmar abduction as measured by goniometer [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ]
    thumb range of motion
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 28, 2015)
Number of participants with Adverse Events [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Procedure: LRTI
  • Device: Biotenodesis Screw
Study Arms  ICMJE
  • Active Comparator: LRTI without a Biotenodesis Screw
    Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw
    Intervention: Procedure: LRTI
  • Active Comparator: LRTI with Biotenodesis Screw
    Ligament Reconstruction Tendon Interposition with Biotenodesis Screw
    Interventions:
    • Procedure: LRTI
    • Device: Biotenodesis Screw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date February 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02352610
Other Study ID Numbers  ICMJE 2015-239
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Trenholm, Nova Scotia Health Authority
Study Sponsor  ICMJE Andrew Trenholm
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nova Scotia Health Authority
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP