Use of FlexHD as Post Trapeziectomy Spacer

Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial

— MTF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998594
• Other study ID #: 00027968
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Department of Hand Surgery	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ellis CV, Kulber DA. Acellular dermal matrices in hand reconstruction. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):256S-69S. doi: 10.1097/PRS.0b013e318265a5cf. Review. Erratum in: Plast Reconstr Surg. 2012 Dec;130(6):1399. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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