NCT01121874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

April 12, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2012

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

April 9, 2010

Last Update Submit

August 14, 2018

Conditions

Thumb Carpometacarpal Arthritis

Keywords

CMC arthritisthumb carpometacarpal arthritisbasal joint arthritisthumb CMC arthritis

Outcome Measures

Primary Outcomes (6)

  • 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).

    Baseline

  • Overall Functionality

    6 wks

  • Overall Functionality

    3 mos

  • Overall Functionality

    6 mos

  • Overall Functionality

    12 months

  • Overall Functionality

    24 months

Secondary Outcomes (5)

  • Analog pain scale

    Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

  • Strength measures

    Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

  • Range of motion

    Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

  • Operative time

    Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

  • Scaphometacarpal distance

    Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

Study Arms (3)

LRTI

ACTIVE COMPARATOR

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.

Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)

Suture fixation system

EXPERIMENTAL

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

Procedure: Ligament reconstruction with suture fixation system

Suture fixation system + 2 week immobilization

EXPERIMENTAL

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.

Procedure: Ligament reconstruction with suture fixation system

Interventions

Ligament reconstruction with suture fixation systemPROCEDURE

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

Also known as: Arthrex Mini TightRope
Suture fixation system
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.

LRTI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

Study Officials

  • Michael Shuler, MD

    Athens Orthopedic Clinic, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hand and Upper Extremity Specialist

Study Record Dates

First Submitted

April 9, 2010

First Posted

May 12, 2010

Study Start

April 12, 2010

Primary Completion

May 21, 2012

Study Completion

July 25, 2012

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)