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

Primary Purpose

Thumb Carpometacarpal Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ligament reconstruction with suture fixation system
Ligament Reconstruction with Tendon Interposition (LRTI)
Ligament reconstruction with suture fixation system
Sponsored by
J&M Shuler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Carpometacarpal Arthritis focused on measuring CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Athens Orthopedic Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

LRTI

Suture fixation system

Suture fixation system + 2 week immobilization

Arm Description

These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.

CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.

CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery.

Outcomes

Primary Outcome Measures

Overall functionality
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).
Overall Functionality
Overall Functionality
Overall Functionality
Overall Functionality
Overall Functionality

Secondary Outcome Measures

Analog pain scale
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.
Strength measures
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Range of motion
Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Operative time
Operative time in minutes
Scaphometacarpal distance
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views

Full Information

First Posted
April 9, 2010
Last Updated
August 14, 2018
Sponsor
J&M Shuler
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1. Study Identification

Unique Protocol Identification Number
NCT01121874
Brief Title
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
Official Title
Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2010 (Actual)
Primary Completion Date
May 21, 2012 (Actual)
Study Completion Date
July 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
J&M Shuler

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Carpometacarpal Arthritis
Keywords
CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LRTI
Arm Type
Active Comparator
Arm Description
These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.
Arm Title
Suture fixation system
Arm Type
Experimental
Arm Description
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
Arm Title
Suture fixation system + 2 week immobilization
Arm Type
Experimental
Arm Description
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery.
Intervention Type
Procedure
Intervention Name(s)
Ligament reconstruction with suture fixation system
Other Intervention Name(s)
Arthrex Mini TightRope
Intervention Description
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Intervention Type
Procedure
Intervention Name(s)
Ligament Reconstruction with Tendon Interposition (LRTI)
Intervention Description
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
Intervention Type
Procedure
Intervention Name(s)
Ligament reconstruction with suture fixation system
Other Intervention Name(s)
Arthrex Mini TightRope
Intervention Description
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.
Primary Outcome Measure Information:
Title
Overall functionality
Description
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).
Time Frame
Baseline
Title
Overall Functionality
Time Frame
6 wks
Title
Overall Functionality
Time Frame
3 mos
Title
Overall Functionality
Time Frame
6 mos
Title
Overall Functionality
Time Frame
12 months
Title
Overall Functionality
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Analog pain scale
Description
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.
Time Frame
Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Title
Strength measures
Description
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Time Frame
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Title
Range of motion
Description
Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Time Frame
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Title
Operative time
Description
Operative time in minutes
Time Frame
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Title
Scaphometacarpal distance
Description
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views
Time Frame
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shuler, MD
Organizational Affiliation
Athens Orthopedic Clinic, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athens Orthopedic Clinic
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States

12. IPD Sharing Statement

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

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