- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998594
Use of FlexHD as Post Trapeziectomy Spacer (MTF)
January 3, 2019 updated by: David Kulber, MD, Cedars-Sinai Medical Center
Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Department of Hand Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arthroplasty without HADM
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.
|
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
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality
Time Frame: 12 months
|
The objective of this study is to determine whether utilizing HADM will result in increased functionality measured by:
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Kulber, MD, Cedars-Sinai Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
November 13, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
December 2, 2013
Study Record Updates
Last Update Posted (Actual)
January 7, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00027968
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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