Use of FlexHD as Post Trapeziectomy Spacer

NCT01998594 | Completed Phase 4

• 1 other identifier: 00027968
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Keywords

Thumb arthritis; CMC arthritis; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

Arthroplasty without HADM

ACTIVE COMPARATOR

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.

Procedure: Arthroplasty

Arthroplasty with HADM

EXPERIMENTAL

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.

Procedure: Arthroplasty

Interventions

Arthroplasty PROCEDURE

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.

Arthroplasty with HADM; Arthroplasty without HADM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

Cedars-Sinai Department of Hand Surgery

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• 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.

  PMID: 23096981 BACKGROUND

• 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.

  PMID: 25289260 BACKGROUND

• 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.

  PMID: 22305824 BACKGROUND

MeSH Terms

Interventions

Arthroplasty

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• David Kulber, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Plastic Surgery, Center of Excellence, Cedars Sinai; Clinical Professor of Surgery, USC Keck School of Medicine

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: December 2, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

US (1)