Fracture Repair, Tendon Repair, Tenolysis
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEVersaWrap
VersaWrap is applied to the affected tendon to allow post-operative gliding.
Sponsors
Research Source
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants diagnosed with post-operative tenolysis | 6 months |
Countries
United States
Outcome results
None listed