Alafair Biosciences Initiates Multi-Center Study on VersaWrap® for Achilles Tendon Repair

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-25

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Alafair Biosciences announced the enrollment of the first patient in a multi-center study evaluating VersaWrap®, a bioresorbable tendon protector, for Achilles tendon repair. The B.R.A.A.D. study will assess VersaWrap's effectiveness in reducing postoperative complications like tendon tethering. VersaWrap is a hyaluronic acid and alginate-based device designed to improve tendon gliding and reduce scar tissue formation, potentially leading to faster healing and improved range of motion. The study's results are expected to inform future product development and enhance the understanding of soft tissue protection in tendon repair.

Key Highlights

  • First patient enrolled in a multi-center study evaluating VersaWrap® for Achilles tendon repair.
  • VersaWrap® aims to reduce postoperative complications such as tendon tethering and improve tendon gliding.
  • The study will assess the long-term impact on patient outcomes, including range of motion and pain reduction.
  • VersaWrap® is a bioresorbable, sutureless tendon protection device made of hyaluronic acid and alginate.

Incidence and Prevalence

Global Epidemiology of Achilles Tendon Repair

Based on the available information, there are limited specific global epidemiological data on Achilles tendon repair. The existing data points include:

  • The Achilles tendon is the body's strongest and largest tendon
  • It is commonly injured, particularly among athletes, accounting for a significant portion of serious tendon injuries
  • One study identified 7010 individuals who had undergone Achilles tendon rupture repair from the American College of Surgeons' National Surgical Quality Improvement Project (NSQIP) database from 2005 to 2021
  • In a study of professional soccer players, 24 athletes with Achilles ruptures were identified between 1988 and 2014
  • These soccer players had an average of 8.3 years of professional-level experience prior to sustaining an Achilles rupture
  • 70.8% (17 out of 24) of professional soccer players were able to return to play after Achilles tendon repair
  • 29.2% of professional soccer players were prevented from returning to play despite surgical management
  • In one surgical approach study, 29 patients (25.0%) had the minimally invasive approach, while 87 patients (75.0%) had the open approach for Achilles tendon repair
  • Another study followed 78 patients who underwent Achilles tendon repair with at least 1-year postoperative follow-up
  • One study included 18 badminton players (age = 48.9±10.0 years) with unilateral Achilles tendon rupture and 177 non-injured players (age = 55.4±9.4 years) as controls

The available information does not provide comprehensive global incidence rates, prevalence statistics, or geographic variations in Achilles tendon ruptures and repairs across different countries and continents.

Study Design Parameters

Study Design Parameters and Endpoints in Achilles Tendon Repair Trials

Study Design Parameters

Various study designs have been employed in Achilles tendon repair research, including:

  • Randomized controlled trials (RCTs) with large sample sizes (e.g., 522 athletes)
  • Prospective cohort studies comparing different treatment devices
  • Discrete-choice experiments conducted with 58 adults following a three-arm randomized clinical trial
  • N of 1, two contemporary arm, open label, randomized controlled clinical trials
  • Retrospective studies comparing different surgical approaches
  • Systematic reviews synthesizing evidence across multiple studies
  • Meta-analyses performed according to PRISMA guidelines

The studies typically involve comparative analyses between different treatment approaches: - Nonoperative treatment versus open repair versus minimally invasive repair - Neuromuscular training programs versus usual care - Ultrasound-guided percutaneous repair versus open repair - Supervised exercises plus conventional treatment versus conventional treatment alone - Autologous platelet lysate versus "wait and see" strategy

One meta-analysis included clinical trials of evidence level I to III comparing minimally invasive versus open surgery, with data from 2223 surgical procedures (1055 open, 1168 minimally invasive) and a mean follow-up of 24.29±22.4 months.

Primary and Secondary Endpoints

The studies utilized various endpoints to assess treatment outcomes:

Clinical Evaluation Scales

  • Arner-Lindholm scale
  • American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot score
  • Achilles Tendon Total Rupture Score (ATRS)
  • Visual Analog Scale (VAS) for pain assessment

Functional Outcomes

  • Time to single heel raise
  • Bilateral calf circumferences
  • Recovery of athletic ability
  • Achilles tendon resting angle (ATRA) at 1-year follow-up
  • Tendon elongation measurements
  • Plantar pressure distribution

Other Key Endpoints

  • Recurrent ankle sprains measured by Hazard Ratio and relative risk
  • Interface pressure measurements at various anatomical points
  • Patient preferences for treatment attributes
  • Patient satisfaction including overall and aesthetic satisfaction
  • Recovery speed and return to sport/work timeframes
  • Complications including sural nerve injury

Comparative Outcomes Between Surgical Approaches

When comparing open repair versus minimally invasive surgical repair (MIS) in patients with Achilles tendon rupture:

  • The MIS group showed significantly superior ATRS scores (78.8±7.4) compared to the open repair group (56.4±15.4) (p<0.001)
  • The average AOFAS score was "excellent" (93±2.8) in the MIS group, while it was "good" (87.4±5.6) in the open repair group
  • Tendon elongation was significantly less in the MIS group (11.3±2 mm) compared to the open repair group (17.3±4.3 mm) (p<0.001)
  • The open repair group showed significantly higher plantar pressure distribution in certain gait phases compared to uninjured extremities
  • There was no significant difference in plantar pressure distribution between uninjured extremities and the MIS group

These findings suggest that minimally invasive surgery is associated with less tendon elongation, more normal plantar pressure distributions, and superior clinical outcomes compared to open surgical repair for acute Achilles tendon repair.

Analysis Approaches

Studies employed various analytical methods: - Per protocol (PP) analysis - Intention-to-treat analysis - Best evidence synthesis in systematic reviews - Statistical analyses using tools like Review Manager Software Version 5.3 - Continuous data analysis through the inverse variance method - Dichotomous data analysis through the Mante-Haenszel method - Confidence intervals set at 95% with p-values <0.05 considered statistically significant

VersaWrap® Clinical Applications Beyond Achilles Tendon Repair

Based on the provided context, there is no specific information available about VersaWrap® being trialed for indications other than Achilles tendon repair. The context does not contain details about:

  • Additional clinical indications beyond Achilles tendon reconstruction
  • Intervention methodologies for non-Achilles tendon applications
  • Enrollment criteria, outcome measures, or study designs for peripheral nerve repair or other soft tissue regeneration applications

Without specific information in the provided context, I cannot provide details about other indications, intervention models, or clinical trial protocols for VersaWrap® beyond Achilles tendon repair.