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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah
ClinicalTrials.gov Identifier:
NCT01425034
First received: August 22, 2011
Last updated: July 17, 2014
Last verified: July 2014
  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:


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 2015
Estimated Primary Completion Date: July 2015 (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 two 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Douglas Hutchinson, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01425034     History of Changes
Other Study ID Numbers: 49860
Study First Received: August 22, 2011
Last Updated: July 17, 2014
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 September 18, 2014