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Completed

NCT Number: NCT01998594

Use of FlexHD as Post Trapeziectomy Spacer

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.

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Key information

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedars-Sinai Department of Hand Surgery

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Functionality

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Musculoskeletal Transplant Foundation

Registry information

Official study title

Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis

Acronym: MTF

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 2, 2013
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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