Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition

NCT01425034 | Completed

• 1 other identifier: 49860
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Keywords

Cast; motion; thumb CMC arthritis; Collateral Ligament of Metacarpophalangeal Joint

Outcome Measures

Primary Outcomes (1)

• compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI)

  DASH, VAS for pain, VAS for satisfaction, pinch and grip strength, coordination test and range of motion (thumb opposition)

  2 years

Study Arms (2)

Cast group

ACTIVE COMPARATOR

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

Motion group

ACTIVE COMPARATOR

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

Interventions

casts for the thumb OTHER

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.

Also known as: Cast group

Cast group

Motion group OTHER

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.

Motion group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Revision LRTI

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

InterMountain Health Care-TOSH orthopedic center

Murray, Utah, 84107, United States

Location

Study Officials

• Douglas Hutchinson, M.D,

  University of Utah Orthopedics Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 29, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)