Use of FlexHD as Post Trapeziectomy Spacer (MTF)

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Treatments: Procedure: Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01998594

00027968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arthroplasty without HADM

Active Comparator group

Description:

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.

Treatment:

Procedure: Arthroplasty

Arthroplasty with HADM

Experimental group

Description:

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.

Treatment:

Procedure: Arthroplasty