Use of FlexHD as Post Trapeziectomy Spacer — MTF  

Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthrosis of the Carpometacarpal Joint of the Thumb

• NCT number: NCT01998594
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Completion date: December 2017