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Use of FlexHD as Post Trapeziectomy Spacer (MTF)

Primary Purpose

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Arthroplasty
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis of the Carpometacarpal Joint of the Thumb focused on measuring Thumb arthritis, CMC arthritis, Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Department of Hand Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthroplasty without HADM

Arthroplasty with HADM

Arm Description

Three - five (3 - 5) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the basilar joint arthroplasty procedure without using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of twenty-five (25) similar subjects who received the arthroplasty procedure with the use of the HADM spacer.

Twent-five (25) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the 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 and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of three - five (3 - 5) similar subjects who received the arthroplasty procedure without the use of the HADM spacer.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 13, 2013
Last Updated
January 3, 2019
Sponsor
Cedars-Sinai Medical Center
Collaborators
Musculoskeletal Transplant Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01998594
Brief Title
Use of FlexHD as Post Trapeziectomy Spacer
Acronym
MTF
Official Title
Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Musculoskeletal Transplant Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Keywords
Thumb arthritis, CMC arthritis, Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroplasty without HADM
Arm Type
Active Comparator
Arm Description
Three - five (3 - 5) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the basilar joint arthroplasty procedure without using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of twenty-five (25) similar subjects who received the arthroplasty procedure with the use of the HADM spacer.
Arm Title
Arthroplasty with HADM
Arm Type
Experimental
Arm Description
Twent-five (25) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the 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 and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of three - five (3 - 5) similar subjects who received the arthroplasty procedure without the use of the HADM spacer.
Intervention Type
Procedure
Intervention Name(s)
Arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functionality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kulber, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Department of Hand Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23096981
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. Erratum In: Plast Reconstr Surg. 2012 Dec;130(6):1399.
Results Reference
background
PubMed Identifier
25289260
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.
Results Reference
background
PubMed Identifier
22305824
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.
Results Reference
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Use of FlexHD as Post Trapeziectomy Spacer

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