Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

NCT06085586 | Recruiting DMC

• 1 other identifier: 2022-08-15-MMC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Fractures; Bimalleolar Fractures; Syndesmotic Injuries; Bimalleolar Equivalent Fracture; Maisonneuve Fracture; Trimalleolar Fractures; Ankle Dislocation

Keywords

Ankle Fractures; Bimalleolar Fractures; Bimalleolar Equivalent Fracture; Trimalleolar Fractures; Maisonneuve Fractures; Syndesmotic Injuries; Ankle Dislocations

Outcome Measures

Primary Outcomes (1)

• 6 Month Reduction Quality

  The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.

  6 Months

Secondary Outcomes (10)

• 2 Week Reduction Quality

  2 Weeks

• 4-6 Week Reduction Quality

  4-6 Weeks

• 8-10 Week Reduction Quality

  8-10 Weeks

• 3 Month Reduction Quality

  3 Months

• Reoperation or Revision

  6 Months

Study Arms (2)

1) Early Full Weight Bearing

EXPERIMENTAL

Full weight bearing (100%) initiated at 4 weeks postoperatively

Other: Early Weight Bearing

2) Normal Full Weight Bearing

ACTIVE COMPARATOR

Full weight bearing (100%) initiated at 6 weeks postoperatively

Other: Normal Weight Bearing

Interventions

Early Weight Bearing OTHER

Full weight bearing (100%) initiated at 4 weeks postoperatively

1) Early Full Weight Bearing

Normal Weight Bearing OTHER

Full weight bearing (100%) initiated at 6 weeks postoperatively

2) Normal Full Weight Bearing

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Maimonides Medical Center: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Desai S. Syndesmosis Repair: 14 Patient Case Series.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013 Dec;6(4):304-12. doi: 10.1007/s12178-013-9184-9.

  PMID: 23949902 BACKGROUND

• Cottom JM, Hyer CF, Philbin TM, Berlet GC. Transosseous fixation of the distal tibiofibular syndesmosis: comparison of an interosseous suture and endobutton to traditional screw fixation in 50 cases. J Foot Ankle Surg. 2009 Nov-Dec;48(6):620-30. doi: 10.1053/j.jfas.2009.07.013. Epub 2009 Sep 15.

  PMID: 19857816 BACKGROUND

• Thornes, Brian FRCSI; McCartan, Damien MB. Ankle Syndesmosis Injuries Treated with the TightRopeTM Suture-Button Kit. Techniques in Foot & Ankle Surgery 5(1):p 45-53, March 2006.

  BACKGROUND

• Latham AJ, Goodwin PC, Stirling B, Budgen A. Ankle syndesmosis repair and rehabilitation in professional rugby league players: a case series report. BMJ Open Sport Exerc Med. 2017 Apr 1;3(1):e000175. doi: 10.1136/bmjsem-2016-000175. eCollection 2017.

  PMID: 28761696 BACKGROUND

• Cotton FJ. Dislocations and Joint-Fractures. Philadelphia: W. B. Saunders Company, 1910.

  BACKGROUND

• Ebraheim NA, Lu J, Yang H, Mekhail AO, Yeasting RA. Radiographic and CT evaluation of tibiofibular syndesmotic diastasis: a cadaver study. Foot Ankle Int. 1997 Nov;18(11):693-8. doi: 10.1177/107110079701801103.

  PMID: 9391813 BACKGROUND

• Harper MC, Keller TS. A radiographic evaluation of the tibiofibular syndesmosis. Foot Ankle. 1989 Dec;10(3):156-60. doi: 10.1177/107110078901000308.

  PMID: 2613128 BACKGROUND

• Leeds HC, Ehrlich MG. Instability of the distal tibiofibular syndesmosis after bimalleolar and trimalleolar ankle fractures. J Bone Joint Surg Am. 1984 Apr;66(4):490-503.

  PMID: 6423645 BACKGROUND

• Rigby RB, Cottom JM. Does the Arthrex TightRope(R) provide maintenance of the distal tibiofibular syndesmosis? A 2-year follow-up of 64 TightRopes(R) in 37 patients. J Foot Ankle Surg. 2013 Sep-Oct;52(5):563-7. doi: 10.1053/j.jfas.2013.04.013. Epub 2013 Jun 14.

  PMID: 23770192 BACKGROUND

• Mukhopadhyay S, Metcalfe A, Guha AR, Mohanty K, Hemmadi S, Lyons K, O'Doherty D. Malreduction of syndesmosis--are we considering the anatomical variation? Injury. 2011 Oct;42(10):1073-6. doi: 10.1016/j.injury.2011.03.019. Epub 2011 May 6.

  PMID: 21550047 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries; Fibula Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Amr A Abdelgawad, MD PhD MBA

  Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Abdelgawad, MD PhD MBA

CONTACT

7182837400; aabdelgawad@maimonidesmed.org

Ariel N Rodriguez, MD

CONTACT

7182837400; arrodriguez@maimonidesmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: July 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)