A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand

Research Source17 enrolled

Overview

The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the hand/fingers, including tendon repair, fracture repair, or tenolysis of the hand/fingers. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

This is a prospective, post-market, observational, single center study evaluating the use of VersaWrap. Patients identified by the Investigator in his practice as needing surgery of the hand/fingers and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tendon Repair Fracture Repair Tenolysis

Interventions

VersaWrapDEVICE

VersaWrap is applied to the affected tendon to allow post-operative gliding.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 18-70 at the time of surgery 2. Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis 3. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance. Exclusion Criteria: 1. Non-English speaking 2. Known allergy or sensitivity to citrate, alginate or hyaluronate 3. Pregnant or breastfeeding 4. Currently a prisoner 5. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol

Locations (1)

Austin Hand Group

Austin, Texas, United States

Outcomes

Primary Outcomes

Number of participants diagnosed with post-operative tenolysis

Time frame: 6 months

Data from ClinicalTrials.gov

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