Trial record 3 of 11 for:    Open Studies | "Thumb"

Use of FlexHD as Post Trapeziectomy Spacer (MTF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Cedars Sinai Medical Care Foundation
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
David Kulber, MD, Cedars Sinai Medical Care Foundation
ClinicalTrials.gov Identifier:
NCT01998594
First received: November 13, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Procedure: Arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis

Further study details as provided by Cedars Sinai Medical Care Foundation:

Primary Outcome Measures:
  • Functionality [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arthroplasty without HADM
Thirty (30) 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 thirty (30) similar subjects who received the arthroplasty procedure with the use of the HADM spacer.
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.
Experimental: Arthroplasty with HADM
Thirty (30) 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 thirty (30) similar subjects who received the arthroplasty procedure without the use of the HADM spacer.
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.

Detailed Description:

Subjects will be followed for 24 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 day 7, day 14, day 21, week 6, month 6, year 1 and at year 2 post-operatively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998594

Contacts
Contact: Sandra Rodriguez, LVN (310) 423-6500 RodriguezSV@csmns.org
Contact: Carolina Paniagua (310) 423-1978 Paniaguac@csmns.org

Locations
United States, California
Cedars-Sinai Department of Hand Surgery Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: David Kulber, MD         
Sponsors and Collaborators
Cedars Sinai Medical Care Foundation
Musculoskeletal Transplant Foundation
Investigators
Principal Investigator: David Kulber, MD Cedars Sinai Medical Care Foundation
  More Information

Publications:
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, Feb 3. [Epub ahead of print]

Responsible Party: David Kulber, MD, Director Plastic Surgery, Center of Excellence, Cedars Sinai; Clinical Professor of Surgery, USC Keck School of Medicine, Cedars Sinai Medical Care Foundation
ClinicalTrials.gov Identifier: NCT01998594     History of Changes
Other Study ID Numbers: 00027968
Study First Received: November 13, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars Sinai Medical Care Foundation:
Thumb arthritis
CMC arthritis
Arthroplasty

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014