Clinical trial NCT01998594: Use of FlexHD as Post Trapeziectomy Spacer
Official title: Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Keywords: Thumb arthritis
CMC arthritis
Arthroplasty
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2013-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.

Detailed description: Subjects will be followed for 12 months post basilar joint arthroplasty procedure with an interposition arthroplasty technique using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores, quality of life and trapezial space on radiographs are compared to their preoperative scores. Study visits will coincide with standard clinical course visits including: Pre-operative visits and follow-up visits at week 6, month 6, and year 1 post-operatively.

Eligibility criteria: Inclusion Criteria:

* Male or Female \>18 years of age
* Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
* Basilar Joint Arthritis Eaton Stage III or IV
* Be in good health other than the arthritis
* Have realistic expectations of surgical results
* Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

* Have collagen-vascular, connective tissue, or bleeding disorders
* Be a smoker or have smoked in last 2 months
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have regional sympathetic dystrophy
* Be pregnant, lactating or expecting to be within the next 24 months

Primary outcomes:
measure: Functionality
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Department of Hand Surgery
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: David Kulber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis CV, Kulber DA. Acellular dermal matrices in hand reconstruction. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):256S-269S. doi: 10.1097/PRS.0b013e318265a5cf.
citation: Yao CA, Ellis CV, Cohen MJ, Kulber DA. Preserving the posttrapeziectomy space with a human acellular dermal matrix spacer: a pilot case series of patients with thumb carpometacarpal joint arthritis. Plast Reconstr Surg Glob Open. 2013 Nov 7;1(7):e65. doi: 10.1097/GOX.0b013e3182aa8793. eCollection 2013 Oct.
citation: Gangopadhyay S, McKenna H, Burke FD, Davis TR. Five- to 18-year follow-up for treatment of trapeziometacarpal osteoarthritis: a prospective comparison of excision, tendon interposition, and ligament reconstruction and tendon interposition. J Hand Surg Am. 2012 Mar;37(3):411-7. doi: 10.1016/j.jhsa.2011.11.027. Epub 2012 Feb 3.