VersaWrap for Flexor Tendon Injuries

Overseen By Stephan Alvarez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Allergies, Psychiatric problems, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-surgery

42 Participants Needed

Trial Summary

What is the purpose of this trial?

To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the VersaWrap treatment for flexor tendon injuries?

The research highlights that modern surgical techniques and rehabilitation protocols have significantly improved outcomes for flexor tendon repairs, suggesting that treatments like VersaWrap, which may incorporate these advancements, could be effective. Techniques such as multistrand suture repairs and early active motion are key to successful tendon repair, which could support the use of VersaWrap as a tendon protector. ^{1 2 3 4 5}

What makes the VersaWrap treatment for flexor tendon injuries unique compared to other treatments?

The VersaWrap treatment for flexor tendon injuries is unique because it involves a specialized surgical procedure that may incorporate advanced techniques like multistrand repairs and early active motion, which are not standard in all flexor tendon surgeries. This approach aims to improve healing and function by using up-to-date surgical and rehabilitation methods. ^{1 2 5 6 7}

Research Team

Ellen Satteson, MD

Principal Investigator

University of Florida

Eligibility Criteria

Adults with a zone 2 flexor tendon injury needing surgery can join this trial. They must be able to follow up post-surgery. People allergic to certain polysaccharides, those with serious medical or psychiatric issues, pregnant or breastfeeding women, and prisoners are excluded.

Inclusion Criteria

I need surgery for a tendon injury in my hand.

Exclusion Criteria

Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate

I cannot have surgery due to my psychiatric or medical condition.

I am willing and able to follow up with my doctor's appointments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Zone 2 flexor tendon repair with or without VersaWrap Tendon Protector

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 2 weeks, 6 weeks, and 3 months post-surgery

3 months

3 visits (in-person)

Treatment Details

Interventions

• Standard of Care Surgical Procedure
• VersaWrap Treatment

Trial Overview The study is testing if using VersaWrap Tendon Protector on repaired tendons leads to better outcomes than the standard surgical procedure without it. Participants will be randomly assigned to either receive VersaWrap or not after their tendon repair surgery.

Participant Groups

Group I: Group A Active Control 2 Interventions

VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap

Group II: Group B Active Control 1 Intervention

Standard of Care Treatment Arm- Zone 2 flexor tendon repair

Standard of Care Surgical Procedure is already approved in United States, European Union for the following indications:

Approved in United States as Standard of Care Surgical Procedure for Flexor Tendon Repair for:

• Flexor tendon injuries
• Zone 2 flexor tendon injuries

Approved in European Union as Flexor Tendon Repair Surgery for:

• Flexor tendon injuries
• Hand injuries
• Finger injuries

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

For successful flexor tendon repair, using a multistrand core suture with at least 4 strands is essential to enable active range of motion in the finger or thumb after surgery.

Incorporating an epitendinous suture can enhance the strength of the tendon repair, and following a careful post-operative therapy regimen is crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based flexor tendon repair. Mehling, IM., Arsalan-Werner, A., Sauerbier, M.[2014]

Recent advancements in the understanding of injury repair mechanisms have led to improved techniques for treating zone 2 flexor injuries, enhancing patient outcomes.

New suture methods now allow for immediate active flexion post-surgery, which may improve recovery times compared to traditional methods that rely on passive flexion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation after flexor tendon surgery]. Hahn, P., Jacobs, C., Müller-Zimmermann, A.[2006]

Flexor tendon surgery is complex and requires a deep understanding of tendon anatomy and injury status, as well as technical skill in various repair techniques to restore function effectively.

Advancements in flexor tendon surgery are expected to improve outcomes, allowing patients to regain nearly full function of their digits after tendon injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexor tendon injuries. Part 5. Flexor tenolysis, rehabilitation and results. Strickland, JW.[2008]

Over the past 30 years, advancements in multistrand suture repair techniques and rehabilitation protocols have significantly improved the treatment outcomes for intrasynovial flexor tendon injuries.

Current treatment protocols emphasize a strong initial repair followed by passive motion rehabilitation, which is supported by recent clinical and scientific findings on tendon behavior and grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexor tendon repair and rehabilitation: state of the art in 2002. Boyer, MI., Strickland, JW., Engles, D., et al.[2006]

Recent advancements in flexor tendon surgery, including slightly tensioned multistrand repairs and early active motion, have led to improved patient outcomes, particularly for challenging Zone 2 injuries.

The use of wide awake local anesthesia no tourniquet (WALANT) during surgery allows for intraoperative active movement, which can be tailored to individual patient needs, enhancing the effectiveness of the repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting Better Results in Flexor Tendon Surgery and Therapy. Ayhan, E., Tuna, Z., Oksuz, C.[2021]

The authors suggest that improving flexor tendon repair can be achieved through the use of simpler yet stronger sutures, proper venting of the pulley system, and early rehabilitation, which may enhance recovery outcomes.

There is a need for ongoing research to better understand and modify adhesions that can form after tendon repair surgery, as these can impact the overall success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary flexor tendon surgery: the search for a perfect result. Elliot, D., Giesen, T.[2013]

Flexor tendon injuries, often caused by penetrating trauma, require surgical repair for complete lacerations, and various techniques are available for effective repair depending on the tendon zone.

Postoperative rehabilitation is crucial for successful recovery, with several rehabilitation protocols outlined to enhance outcomes after tendon repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Considerations for Flexor Tendon Repair: Timing and Choice of Repair Technique and Rehabilitation. Sasor, SE., Chung, KC.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence-based flexor tendon repair. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

[Rehabilitation after flexor tendon surgery]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Flexor tendon injuries. Part 5. Flexor tenolysis, rehabilitation and results. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Flexor tendon repair and rehabilitation: state of the art in 2002. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Getting Better Results in Flexor Tendon Surgery and Therapy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Primary flexor tendon surgery: the search for a perfect result. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical Considerations for Flexor Tendon Repair: Timing and Choice of Repair Technique and Rehabilitation. [2023]