Use of FlexHD as Post Trapeziectomy Spacer

Phase 4CompletedNCT01998594

Cedars-Sinai Medical Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Interventions

ArthroplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cedars-Sinai Department of Hand Surgery

Los Angeles, California, United States

Outcomes

Primary Outcomes

Functionality

The objective of this study is to determine whether utilizing HADM will result in increased functionality measured by: * DASH score * Pinch and grip strength * Pain scale * Quality of life scores and * Trapezial space on radiographs at designated intervals during the post-operative period

Time frame: 12 months

Data from ClinicalTrials.gov

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