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NCT06085586
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
NA trial testing Early Weight Bearing in Ankle Fractures in 56 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Maimonides Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 13 July 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Early Weight Bearing
- Normal Weight Bearing
Conditions studied
- Ankle Fractures — all drugs for Ankle Fractures →
- Bimalleolar Fractures — all drugs for Bimalleolar Fractures →
- Syndesmotic Injuries — all drugs for Syndesmotic Injuries →
- Bimalleolar Equivalent Fracture — all drugs for Bimalleolar Equivalent Fracture →
Sponsor
Maimonides Medical Center
Who can join
22 and older, any sex, with Ankle Fractures or Bimalleolar Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06085586
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Early Weight Bearing
Trials testing the same drug.
- NCT02475941 — Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients · NA · completed
Other recruiting trials for Ankle Fractures
Currently open trials in the same condition.
- NCT06370325 — Neuromuscular Electrical Stimulation in Foot and Ankle Surgery · NA · recruiting
- NCT06568276 — The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures · NA · recruiting
- NCT05413707 — Weber B Ankle Fractures With Associated Posterior Malleolus Fracture · NA · recruiting
- NCT05555459 — Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation · NA · recruiting
- NCT05280639 — Simplified Post Op Rehabilitation for Ankle and Pilon Fractures · NA · recruiting
Other Maimonides Medical Center trials
Trials by the same sponsor.
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- NCT06107725 — Maimonides Minocycline in Stroke Study · Phase 2, PHASE3 · terminated
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06085586 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maimonides Medical Center
- Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06085586.
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