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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352610
• Other study ID #: 2015-239
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2018
• Est. primary completion date: February 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• LRTI

Device:
• Biotenodesis Screw

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Trenholm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with Adverse Events		Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Primary	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	EQ-5D Health Questionnaire Score		Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	DASH questionnaire score		Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Grip strength as measured by dynamometer		Baseline, 3 months, 6 months, 1 year, 2 years
Secondary	Pinch strength as measured by dynamometer		Baseline, 3 months, 6 months, 1 year, 2 years
Secondary	Opposition as measured by goniometer	thumb range of motion	Baseline, 3 months, 6 months, 1 year, 2 years
Secondary	Radial abduction as measured by goniometer	thumb range of motion	Baseline, 3 months, 6 months, 1 year, 2 years
Secondary	Palmar abduction as measured by goniometer	thumb range of motion	Baseline, 3 months, 6 months, 1 year, 2 years
Secondary	Pain score on the visual analogue scale	visual analogue scale	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years