Lateral Ankle InstabilityNCT06829667
Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
An observational study of Lateral Ankle Instability, run by Stryker Trauma and Extremities at 4 sites in United States.
Trial summary
This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Lateral Ankle Instability
- What is being tested?
- Arthrex InternalBrace
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Oct 2023to 8 Apr 2026
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace
Who may be able to join
- Patients between and including the age of 14-75 at the time of surgery
- Patients who were diagnosed with lateral ankle instability by physician clinical assessment
- Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)
Who cannot join
- Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (Minor microfractures and OCD lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed)
- Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
- Patients undergoing a Calcaneal osteotomy
- Patients with less than 6 weeks follow-up
- Patients with incomplete medical records
- Patients with Worker's Compensation Cases
Show all 9Show fewer
- Any patient with a history of infection of the ankle predating the ankle repair
- Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
- Patients who have a medical history that would likely make the patient an unreliable research participant
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ERLANGER
Chattanooga, Tennessee, 37403
KUMC
Kansas City, Kansas, 66103
Seaview Orthopaedics
Ocean City, New Jersey, 07712
MORE Foundation
Phoenix, Arizona, 85023
About this study
Official title: An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.
- Conditions
- Lateral Ankle Instability
- Being tested
- Arthrex InternalBrace
- Keywords
- ATFL reconstructive procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex InternalBraceDevice
Arthrex InternalBrace is composed of a polyethylene/polyester suture tape and knotless bone anchors to provide ligament repair bridging and reinforce ligament strength. There have been conflicting results surrounding the clinical efficacy of its use in lateral ligament reconstruction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Effectiveness
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability.
The assessment of effectiveness will be measured by the rate of complications as defined by those patients that necessitated a return to the OR, including implant failure, symptomatic implant requiring removal, peri-implant fracture, deep wound infection and foreign body reaction.
Measured: 12 weeks to last recorded follow-up
Evaluate Safety
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability.
Safety of study subjects will be established by recording treatment, incidence and frequency of adverse events. Also, adverse events will be classified as procedure related and/or product related.
Measured: 2 weeks to last recorded follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start13 Oct 2023
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829667
- Sponsor's protocol ID
- ART-004
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Unknown at this time
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
- ClinicalTrials.gov ID
- NCT06829667
- Acronym / sponsor ID
- ART-004
- Conditions
- Lateral Ankle Instability
- Keywords
- ATFL reconstructive procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 17 Feb 2025 (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.
This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace
Key inclusion criteria (3 listed)
- Patients between and including the age of 14-75 at the time of surgery
- Patients who were diagnosed with lateral ankle instability by physician clinical assessment
- Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)
Key exclusion criteria (9 listed)
- Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (Minor microfractures and OCD lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed)
- Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
- Patients undergoing a Calcaneal osteotomy
- Patients with less than 6 weeks follow-up
- Patients with incomplete medical records
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 |
|---|---|---|
| Arthrex InternalBraceArthrex InternalBrace is composed of a polyethylene/polyester suture tape and knotless bone anchors to provide ligament repair bridging and reinforce ligament strength. There have been conflicting results surrounding the clinical efficacy of its use in lateral ligament reconstruction. | Device | – |
Primary outcome
Evaluate Effectiveness
Time frame: 12 weeks to last recorded follow-up
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. The assessment of effectiveness will be measured by the rate of complications as defined by those patients that necessitated a return to the OR, including implant failure, symptomatic implant requiring removal, peri-implant fracture, deep wound infection and foreign body reaction.
Evaluate Safety
Time frame: 2 weeks to last recorded follow-up
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. Safety of study subjects will be established by recording treatment, incidence and frequency of adverse events. Also, adverse events will be classified as procedure related and/or product related.
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 1 Sep 2026.
- Individual participant dataSharing planned: No. Unknown at this time
Related trials for Lateral Ankle Instability
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability
Recruiting
Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
Ankle Instability
Recruiting
Dynamic Neuromuscular Stability Exercises With and Without Rhythmic Auditory Stimulation in Lateral Ankle Sprain
Ankle Sprain, Lateral Ankle Sprain
RecruitingObservational study
Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
Ankle Sprain, Hypermobility, Joint
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.
Rebecca Gibson study director
Stryker Trauma & Extremities
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Ankle Instability, run by Stryker Trauma and Extremities at 4 sites 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 9 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Evaluate Effectiveness (time frame: 12 weeks to last recorded follow-up). The study lists 2 primary outcomes in all. 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 1 Sep 2026.