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NCT05662449: Synfix
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture
trial testing Syndesmosis fixation using Activascrew in Syndesmotic Injuries in 40 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | NHS Grampian |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 1 April 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Syndesmosis fixation using Activascrew
Conditions studied
- Syndesmotic Injuries — all drugs for Syndesmotic Injuries →
- Ankle Fractures — all drugs for Ankle Fractures →
- Ankle Injuries and Disorders — all drugs for Ankle Injuries and Disorders →
Sponsor
NHS Grampian — full company profile →
Who can join
Adults 18 to 65, any sex, with Syndesmotic Injuries or Ankle Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws. Ankle fractures are common, and a proportion of them involve both fracture of the bone and also disruption of the syndesmosis, a strong ligamentous complex connecting the distal fibula and tibia. If left without fixation this causes a high incidence of pain and early arthritis. The most common technique for fixation of this syndesmosis involves the use of the same type of metal screws used to fix the fractured bones. As the syndesmosis permits small degrees of movement in normal subjects, fixation of this with metal usually leads to screw breakage and, or pain. It is common practice to remove these screws after a period of time once the syndesmosis has healed in the correct position. Bioabsorbable screws have the advantage of allowing small increments of movement, and also resorb naturally therefore do not have to be removed with a second surgical procedure. They are used in other centres worldwide, and the investigators therefore seek to evaluate syndesmosis fixation with them in their unit. The investigators would aim to recruit patients who have a syndesmotic injury requiring fixation, and who can consent to participating. They would undergo an identical surgical procedure to the standard current practice, apart from using a bioabsorbable screw in exchange for the metallic screw for syndesmosis fixation. All other components would remain unchanged, as would post operative protocol and management. To evaluate the fixation the investigators would use a limited CT scan (equivalent of about 3 months background radiation) after the time of fixation and at one year. This will help to assess the maintenance of reduction of the syndesmosis with time. The investigators would also assess patient reported outcome measures and pain scores, length of procedure and intraoperative radiation levels, weight bearing distribution tests, as well as any complication that may arise.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05662449
- Europe PMC full search
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Related trials
Other recruiting trials for Syndesmotic Injuries
Currently open trials in the same condition.
- NCT06085586 — Fibulink Syndesmosis Repair System With Early Full-Weight Bearing · NA · recruiting
- NCT05413707 — Weber B Ankle Fractures With Associated Posterior Malleolus Fracture · NA · recruiting
- NCT05729542 — Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries · NA · recruiting
- NCT05445960 — Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After A · NA · recruiting
Other NHS Grampian trials
Trials by the same sponsor.
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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 NCT05662449 (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 NHS Grampian
- Last refreshed: 22 December 2022
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/NCT05662449.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing