Skip to main content
OpenTrials
Completed

NCT Number: NCT01121874

Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty

Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.

We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thumb Carpometacarpal Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients aged >18.
  • Eaton Stage III or IV CMC arthritis
  • Failure to respond to conservative treatment

Exclusion criteria

  • Previous surgical interventions on that thumb
  • Upper extremity neurological dysfunction
  • Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
  • Unwilling or unable to provide written informed consent

Treatment and study plan

Ligament reconstruction with suture fixation system

Procedure

CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system

Other names: Arthrex Mini TightRope

Ligament Reconstruction with Tendon Interposition (LRTI)

Procedure

commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.

Primary outcomes

  1. Overall functionality

    Time frame: Baseline

    Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).

  2. Overall Functionality

    Time frame: 6 wks

  3. Overall Functionality

    Time frame: 3 mos

  4. Overall Functionality

    Time frame: 6 mos

  5. Overall Functionality

    Time frame: 12 months

  6. Overall Functionality

    Time frame: 24 months

Secondary outcomes

  1. Analog pain scale

    Time frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

    Pain will be assessed using the visual analog pain scale, which asks the patient to rate their pain on a scale from 1 to 10.

  2. Strength measures

    Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

    Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer

  3. Range of motion

    Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

    Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).

  4. Operative time

    Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

    Operative time in minutes

  5. Scaphometacarpal distance

    Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

    Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views

Sponsors and collaborators

Lead sponsor

J&M Shuler

Industry

Registry information

Official study title

Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 12, 2010
Registry last updated
Aug 15, 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.