Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Официальное название

Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Обзор

The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.

Подробное описание

All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle will be obtained. Manual or gravity stress view will be performed if needed. Treatment options including nonoperative and operative management will be discussed with the patient including the risks and benefits. An informed decision will be made. Two separate informed consent will be obtained. The first will be an informed consent for the surgery, detailing the planned surgical procedure. The second will be an informed consent for the enrollment of the study, detailing the purpose of the study and the use of the Fibulink Syndesmotic Repair System in any cases of syndesmotic injury.

Should the patient elects to proceed with surgery, the patient will be informed that fixation of the fractures will be performed first. Direct lateral approach to the distal fibular will be used for fixation of the lateral malleolus. If necessary, direct medial approach will be used for fixation of the medial malleolus. Once the fractures have been fixed, the syndesmosis will be stressed intraoperatively under live fluoroscopy. Based on the parameters described in 6.3, a decision will be made whether fixation of the syndesmosis is required if instability is noted. If fixation of the syndesmosis is required, it will be performed through the direct lateral approach.

The research coordinator will be informed of all patients that had the syndesmosis fixed with the Fibulink System. Patients will then be followed at the following time points: 2 weeks, 4-6 weeks, 8-10 weeks, 3 months and 6 months. During each follow-up time points, the tibiofibular overlap, tibiofibular clear space and medial clear space will be measured and recorded. The postoperative protocol will be as follow: Immediately post-op, patient will be placed in a short leg cast. At 2 weeks postop, the short leg cast will be removed. Suture removal will be performed. Patient will be placed in a CAM boot and instructed to perform early active ankle range-of-motion. Depending on the study group, at 4 weeks or 6 weeks postop, full weight bearing (100%) in the CAM boot will be allowed. Physical therapy will begin. At 8-10 weeks postop, full weight bearing (100%) without CAM boot will begin. Patients will continue to follow-up at 3 months and 6 months.

The research coordinator will ensure proper follow-up and will be responsible for data collection and input. After achieving the planned number of participants, the results of the two study sites will be gathered. Appropriate statistical analysis will be performed, and the results will be presented in a full manuscript format.

Вмешательства

• Другое Early Weight Bearing
  Full weight bearing (100%) initiated at 4 weeks postoperatively
• Другое Normal Weight Bearing
  Full weight bearing (100%) initiated at 6 weeks postoperatively

Первичные конечные точки

• 6 Month Reduction Quality [Срок оценки: 6 Months]

Вторичные конечные точки (10)

• 2 Week Reduction Quality [Срок оценки: 2 Weeks]
• 4-6 Week Reduction Quality [Срок оценки: 4-6 Weeks]
• 8-10 Week Reduction Quality [Срок оценки: 8-10 Weeks]
• 3 Month Reduction Quality [Срок оценки: 3 Months]
• Reoperation or Revision [Срок оценки: 6 Months]
• OR Time [Срок оценки: 1 Day]
• Surgical Approach/Procedure Type [Срок оценки: 1 Day]
• Type of Additional Fixation [Срок оценки: 1 Day]
• Intraoperative Complications [Срок оценки: 1 Day]
• Postoperative Complications [Срок оценки: 30 Days]

Критерии участия

Критерии включения

• ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.

This includes the following injuries:

• Syndesmotic sprain (without fractures)
• Bimalleolar equivalent ankle fractures
• Bimalleolar ankle fractures
• Maisonneuve fractures
• Trimalleolar ankle fractures without the need for posterior malleolus fixation
• Ankle fracture dislocations

Критерии исключения

• 1\) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Maimonides Medical Center — Brooklyn

Публикации

• Thornes B, Shannon F, Guiney AM, Hession P, Masterson E. Suture-button syndesmosis fixation: accelerated rehabilitation and improved outcomes. Clin Orthop Relat Res. 2005 Feb;(431):207-12. PMID 15685077
• Degroot H, Al-Omari AA, El Ghazaly SA. Outcomes of suture button repair of the distal tibiofibular syndesmosis. Foot Ankle Int. 2011 Mar;32(3):250-6. doi: 10.3113/FAI.2011.0250. PMID 21477543
• Morellato J, Louati H, Bodrogi A, Stewart A, Papp S, Liew A, Gofton W. The Effect of Varying Tension of a Suture Button Construct in Fixation of the Tibiofibular Syndesmosis-Evaluation Using Stress Computed Tomography. J Orthop Trauma. 2017 Feb;31(2):103-110. doi: 10.1097/BOT.0000000000000737. PMID 28129269
• Dynamic and Load-to-Failure Testing of the DePuy Synthes FIBULINK TM Syndesmosis Repair System and Arthrex Syndesmosis TightRope ® XP Implant System Materials and Methods. 2020.
• Desai S. Syndesmosis Repair: 14 Patient Case Series.
• Ramsey PL, Hamilton W. Changes in tibiotalar area of contact caused by lateral talar shift. J Bone Joint Surg Am. 1976 Apr;58(3):356-7. PMID 1262367
• Hunt KJ, Goeb Y, Behn AW, Criswell B, Chou L. Ankle Joint Contact Loads and Displacement With Progressive Syndesmotic Injury. Foot Ankle Int. 2015 Sep;36(9):1095-103. doi: 10.1177/1071100715583456. Epub 2015 May 6. PMID 25948693
• Porter DA, Jaggers RR, Barnes AF, Rund AM. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014 Aug 5;5:173-82. doi: 10.2147/OAJSM.S41564. eCollection 2014. PMID 25177153

Идентификаторы

NCT: NCT06085586 · 2022-08-15-MMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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