Use of FlexHD as Post Trapeziectomy Spacer

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2017

Conditions
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Interventions
PROCEDURE

Arthroplasty

A longitudinal dorsoradial incision is made from the base of the first metacarpal to the radial styloid for access to the thumb CMC joint. Trapeziectomy is performed piecemeal using sharp and blunt dissection. The base of the first metacarpal is then decorticated with a sagittal saw. A 4x7 cm sheet of thin FlexHD (HADM) is fashioned by a 4-0 monocryl suture imbrication into the size and shape of the subject's trapezium, keeping the dermal side exposed as much as possible. The allograft is secured with multiple interrupted 3-0 Ticron sutures and the bundle is placed into the post-trapeziectomy space. Additional suture fixation is performed between the FlexHD and the volar capsule of the trapezium, and base of the thumb metacarpal using 4-0 Mersilene sutures. The control treatment group will have the same trapeziectomy but without the placement of the FlexHD acellular dermal matrix.

Trial Locations (1)

90048

Cedars-Sinai Department of Hand Surgery, Los Angeles

All Listed Sponsors
collaborator

Musculoskeletal Transplant Foundation

OTHER

lead

Cedars-Sinai Medical Center

OTHER

NCT01998594 - Use of FlexHD as Post Trapeziectomy Spacer | Biotech Hunter | Biotech Hunter