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This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthrex Tightrope | Active Comparator | Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. |
|
| Synthes Fibulink | Experimental | Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex Tightrope | Device | High-tensile strength suture syndesmosis repair |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain score | VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain | 1 year |
| Foot and Ankle Disability Index | Functional score with a 0-104 with higher scores indicating better function | 1 year |
| Olerud-Molander Ankle Score | Functional Score with a score of 0-100 with higher scores indicating better function | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with medical or surgical complications | Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominic Baun, MS | Contact | 858-534-8268 | jbaun@health.ucsd.edu | |
| William Kent, MD | Contact | 619-543-2694 | wkent@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Synthes Fibulink |
| Device |
High-tensile strength suture syndesmosis repair |
|