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Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition (LRTI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01425034
First received: August 22, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity treated by hand surgeons in our society. It can be a significant source of functional disability secondary to a painful, and often weak, grip. Once patients have failed treatment by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the next option is surgical management. Several surgical options are available depending on the severity of the disease. For the early stages of arthritis options include a ligament reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage procedures exist. These have included simple trapeziectomy, arthrodesis and implant arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament reconstruction tendon interposition


Condition Intervention
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
 Other: casts for the thumb
Other: Motion group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition: a Prospective, Randomized Multi-center Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    DASH, VAS for pain, VAS for satisfaction, pinch and grip strength, coordination test and range of motion (thumb opposition)


Estimated Enrollment: 210
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cast group
The 'Cast' group will be placed in a thumb spica short arm cast with the thumb IP joint free. They will be allowed digit, thumb IP and elbow range of motion.
 Other: casts for the thumb
The 'Cast' group will be placed in a thumb spica short arm cast with the thumb IP joint free. They will be allowed digit, thumb IP and elbow range of motion.
Other Name: Cast group
Active Comparator: Motion group
The 'Motion' group will be placed in a forearm based thumb spica splint with the thumb IP free. They will be allowed digit, thumb IP and elbow range of motion.
 Other: Motion group
The 'Motion' group will be placed in a forearm based thumb spica splint with the thumb IP free. They will be allowed digit, thumb IP and elbow range of motion.
Other Name: Motion group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 40 years old with basal arthritis who failed conservative treatment
  • Patients receiving LRTI by one of Three enrolled surgeons at the U or one of the wo enrolled surgeons at Intermountain who consented to the study

Exclusion Criteria:

  • Patients undergoing more procedures in addition to the LRTI that may alter the postoperative course, not including CTR or thumb MCP capsulodesis, MP fusion, trigger finger release
  • h/o CRPS
  • RA
  • Revision LRTI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425034

Locations
United States, Utah
InterMountain Health Care-TOSH orthopedic center
Murray, Utah, United States, 84107
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Douglas Hutchinson, M.D, University of Utah Orthopedics Center
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01425034     History of Changes
Other Study ID Numbers: 49860
Study First Received: August 22, 2011
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Cast
motion
thumb CMC arthritis
Collateral Ligament of Metacarpophalangeal Joint

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013