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NCT04459910
Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
trial testing Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair in Ankle Injuries in 29 participants. Completed in 1 January 2021.
1 September 2020
Quick facts
| Lead sponsor | Federal University of São Paulo |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 1 July 2019 |
| Primary completion | 1 September 2020 |
| Estimated completion | 1 January 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair
Conditions studied
- Ankle Injuries — all drugs for Ankle Injuries →
- Ligament Injury — all drugs for Ligament Injury →
- Joint Instability — all drugs for Joint Instability →
- Deltoid Ligament; Sprain (Strain) (Ankle) — all drugs for Deltoid Ligament; Sprain (Strain) (Ankle) →
Sponsor
Federal University of São Paulo
Who can join
Adults 15 to 65, any sex, with Ankle Injuries or Ligament Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Abstract Introduction: The high prevalence of sprains in the population has provided a substantial number of patients with lateral instability of the ankle. The continuity of this condition can lead to the progressive loosening of the medial containment structures, generating a multidirectional rotational instability. The deltoid approach through the imbrication of its components has been proposed as a solution for these patients. The arthroscopic technique has been described as an alternative. Methods: This is a retrospective study with patients diagnosed with multidirectional instability and submitted to an ankle arthroscopy with medial repair (arthroscopic tensioning) and lateral (arthroscopic Brostrom) between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up. Discussion: The combined medial and lateral arthroscopic repair may be an effective and safe alternative in the treatment of multidirectional instability. The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal. Design: Level IV. Retrospective case series. Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability.
Mansur NSB, Lemos AVKC, Baumfeld DS, Baumfeld TS, et al · · 2021 · cited 15× · PMID 35097429 · DOI 10.1177/2473011420986150
Verify or expand the search:
- PubMed search for NCT04459910
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT04459910 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of São Paulo
- Last refreshed: 4 February 2021
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/NCT04459910.
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