Tendon RepairNCT05598801
A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand
An observational study of Tendon Repair and Fracture Repair, run by Research Source at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendon Repair, Fracture Repair, Tenolysis
- What is being tested?
- VersaWrap
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 17 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize the VersaWrap, the patient will be considered a screen failure.
Who may be able to join
- Patients aged 18-70 at the time of surgery
- Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
- 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.
Who cannot join
- Non-English speaking
- Known allergy or sensitivity to citrate, alginate or hyaluronate
- Pregnant or breastfeeding
- Currently a prisoner
- Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Tendon Repair, Fracture Repair, Tenolysis
- Being tested
- VersaWrap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VersaWrapDevice
VersaWrap is applied to the affected tendon to allow post-operative gliding.
| Study group | Role | What they receive |
|---|---|---|
| VersaWrap | All enrolled patients will received VersaWrap applied prior to surgical closure on the affected tendon. Receives: Device: VersaWrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with post-operative tenolysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Sep 2022
- Primary completion17 Aug 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Source
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598801
- Sponsor's protocol ID
- VW-001- Version 02
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand
- ClinicalTrials.gov ID
- NCT05598801
- Acronym / sponsor ID
- VW-001- Version 02
- Conditions
- Tendon Repair, Fracture Repair, Tenolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Research SourceResearch network
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 17 Aug 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VersaWrap | – | Device: VersaWrapAll enrolled patients will received VersaWrap applied prior to surgical closure on the affected tendon. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize the VersaWrap, the patient will be considered a screen failure.
Key inclusion criteria (3 listed)
- Patients aged 18-70 at the time of surgery
- Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
- 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.
Key exclusion criteria (5 listed)
- Non-English speaking
- Known allergy or sensitivity to citrate, alginate or hyaluronate
- Pregnant or breastfeeding
- Currently a prisoner
- Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VersaWrapVersaWrap is applied to the affected tendon to allow post-operative gliding. | Device | VersaWrap |
Primary outcome
Number of participants diagnosed with post-operative tenolysis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendon Repair and Fracture Repair, run by Research Source at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants diagnosed with post-operative tenolysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.