How Artelon Is Changing Soft Tissue Repair
A material that integrates with human tissue and dissolves over time is transforming how surgeons reconstruct damaged ankles.
Imagine an ankle so weakened by repeated sprains that even walking on uneven ground feels treacherous. For patients with severe chronic lateral ankle instability, this is a daily reality. Traditional surgical repairs can be effective, but what if surgeons could augment these repairs with a synthetic material that actively promotes healing and then safely dissolves once its job is done?
This is the promise of Artelon, a revolutionary biomaterial that is changing the landscape of soft tissue reconstruction in foot and ankle surgery. This article explores the science behind this innovation and examines the clinical evidence supporting its safety and effectiveness.
The anterior talofibular ligament (ATFL) is the most commonly injured ligament in the ankle. While most ankle sprains heal with conservative treatment, 10% to 20% of cases progress to chronic instability, characterized by a recurring feeling of the ankle "giving way" . This persistent instability can lead to pain, loss of function, and eventually, arthritis.
The modified Broström procedure—a repair of the damaged ligaments—is the gold standard surgical treatment. However, reoperation rates can be as high as 14% . Surgeons have long sought ways to reinforce these repairs, particularly for patients with poor tissue quality or complex injuries.
10-20%
of ankle sprains progress to chronic instability
Artelon is a synthetic, biodegradable biomaterial composed of a unique co-polymer of polycaprolactone and polyurethane-urea 2 . This combination is engineered to mimic the mechanical properties of natural ligaments and tendons while promoting biological integration.
The material is woven into a textile matrix called FLEXBAND, which possesses three key characteristics that make it ideal for soft tissue augmentation:
| Property | Description | Clinical Benefit |
|---|---|---|
| Material Composition | Polycaprolactone-based polyurethane urea (PUUR) | Biocompatible with controllable degradation |
| Structure | Woven textile with specific porosity | Allows host cell infiltration and tissue integration |
| Mechanical Property | Similar strength to natural ligaments | Provides immediate mechanical support to repairs |
| Degradation Timeline | 4-6 years | Long-term support while promoting tissue regeneration |
Multiple clinical studies have investigated the safety of Artelon in foot and ankle applications, with consistently reassuring findings.
| Complication Type | 2020 Study (55 patients) 1 | 2024 Study (105 patients) 5 |
|---|---|---|
| Major Complications | 2 (3.6%) | 4 (3.8%) |
| Matrix Removal | 1 (1.8%) | 1 (1.0%) |
| Minor Complications | 8 (14.5%) | 8 (7.6%) |
| Foreign Body Reaction | 0 | Not reported |
A 2024 retrospective multicenter study provided particularly compelling evidence by directly comparing Broström procedures with and without Artelon augmentation .
Researchers reviewed charts of 226 patients—83 who underwent Broström procedure alone (MB group) and 143 who received Broström with Artelon augmentation (PUUR group) . They analyzed:
The findings revealed several advantages for the Artelon-augmented group:
The researchers noted that the Artelon group included significantly more complex cases, with nearly all patients requiring additional procedures beyond the ligament repair. Despite this increased complexity, the augmented group still demonstrated superior pain and recovery outcomes .
| Outcome Measure | Broström Alone (MB) | Broström with Artelon (PUUR) | Statistical Significance |
|---|---|---|---|
| Time to Full Weight Bearing (weeks) | 11.4 ± 1.79 | 9.04 ± 0.34 | P = .047 |
| Preoperative VAS Pain Score | 6.39 | 5.54 | Not significant |
| Procedure-Specific Adverse Events | 3.2% | 4.2% | Not significant |
| Patients Requiring Concomitant Procedures | 80.1% | 99.3% | P < .0001 |
Artelon offers several product configurations tailored to different surgical needs 3 :
The flagship system featuring twist-in anchor locking and a MOD cube for intraoperative adaptability
A comprehensive procedure kit with tap-in fixation for single ligament augmentation
Designed for multiple ligament augmentation procedures
A streamlined kit for single ligament augmentation
The FLEXBAND matrix itself is available in multiple widths and lengths, with premium versions featuring integrated suturing to facilitate quick matrix passing and fixation during surgery 3 .
While this article has focused on foot and ankle applications, Artelon has shown promise in other orthopedic settings:
A 2022 study found Artelon safe for collateral ligament augmentation in knee dislocations, with outcomes equivalent to primary repair 8
Case reports describe successful use of Artelon as a bio-scaffold in revision anterior cruciate ligament reconstruction 7
Research indicates bio-scaffold augmentation can promote improved cell adhesion and tendon-like characteristics in rotator cuff repairs 8
While current evidence is promising, research continues. A prospective, blinded, randomized study is currently enrolling patients to further evaluate Artelon FLEXBAND for ATFL reconstruction in lateral ankle instability 4 . This higher-level study will provide additional evidence to guide clinical use.
As one research team concluded, "Additional studies must be done looking at long-term patient outcomes with utilization of Artelon, and direct comparative studies with other soft tissue reconstruction techniques and materials in the foot and ankle" 1 .
The evidence to date suggests that Artelon represents a significant advancement in soft tissue reconstruction. Its unique combination of immediate mechanical support, biological integration, and progressive degradation addresses fundamental limitations of traditional repair techniques.
For patients suffering from chronic ankle instability, this technology offers the potential for:
As research continues and surgical experience grows, synthetic degradable matrices like Artelon may well become standard care for complex soft tissue reconstructions, helping patients regain not just stability, but also their quality of life.