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
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedJuly 17, 2018
July 1, 2018
3 years
January 8, 2015
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subsidence of CMC joint
Measurement of trapezial height as a percentage of pre-operative height
6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary Outcomes (8)
EQ-5D Health Questionnaire Score
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
DASH questionnaire score
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength as measured by dynamometer
Baseline, 3 months, 6 months, 1 year, 2 years
Pinch strength as measured by dynamometer
Baseline, 3 months, 6 months, 1 year, 2 years
Opposition as measured by goniometer
Baseline, 3 months, 6 months, 1 year, 2 years
- +3 more secondary outcomes
Other Outcomes (1)
Number of participants with Adverse Events
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Study Arms (2)
LRTI without a Biotenodesis Screw
ACTIVE COMPARATORLigament Reconstruction Tendon Interposition without a Biotenodesis Screw
LRTI with Biotenodesis Screw
ACTIVE COMPARATORLigament Reconstruction Tendon Interposition with Biotenodesis Screw
Interventions
Eligibility Criteria
You may qualify if:
- First CMC primary osteoarthritis refractory to conservative treatment
- Patient \>age 18
- Able to read and understand English
- Available for 2 year follow up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrew Trenholmlead
Study Sites (1)
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Orthopaedic Surgeon
Study Record Dates
First Submitted
January 8, 2015
First Posted
February 2, 2015
Study Start
March 1, 2015
Primary Completion
February 22, 2018
Study Completion
April 30, 2018
Last Updated
July 17, 2018
Record last verified: 2018-07