Ablation of osteosynthesis material after ankle osteosynthesis: a randomized study.
Résumé de l'étude
Following an ankle surgery, a surgical procedure is often performed where the osteosynthesis material (plates/screws) is removed, in order to reduce discomfort or pain related to the osteosynthesis material. Our research project aims to study whether the effectiveness presented by this surgical procedure is superior to conservative treatment, that is, without surgery. To this end, we will recruit patients who have recently undergone surgery for an ankle fracture. They will then be randomly assigned to one of two groups, either in the group where the material (plate/screws) will be removed, or in the group where the material will be kept in place. Patients will need to complete two questionnaires at the beginning and at the end of the study (at 6 months) and we will then compare the results.
(BASEC)
Intervention étudiée
The ablation of osteosynthesis material, that is, the surgical procedure aimed at removing the plates and screws, after surgery for an ankle fracture.
(BASEC)
Maladie en cours d'investigation
Operated ankle fractures.
(BASEC)
-age > 18 years -surgical operation of the ankle at HFR or RHNe -patients with a FAAM score between 5% and 95% (BASEC)
Critères d'exclusion
-absolute indications for ablation of osteosynthesis material: infection, non-union, metal allergy, refracture -FAAM score <5% or >95% -history of ankle fracture (BASEC)
Lieu de l’étude
Fribourg, Neuchâtel
(BASEC)
Sponsor
HFR Fribourg
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Angela Seidel
+41 26 306 28 02
Angela.Seidel@clutterh-fr.chHFR Fribourg
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
31.08.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05798741 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Hardware Removal after ORIF of ankle fractures: A randomized trial (BASEC)
Titre académique
Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial (ICTRP)
Titre public
Hardware Removal After ORIF of Ankle Fractures (ICTRP)
Maladie en cours d'investigation
Ankle Fractures
(ICTRP)
Intervention étudiée
Procedure: Hardware removal
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- >18 y.o
- Operative treatment of ankle/foot fractures at HFR or RHNe:
- Ankle fractures: bi-malleolar and tri-malleolar fractures or equivalent
- FAAM score >5%, <95%
- Patient expected to complete length of study
- Patient with sufficient cognitive and linguistic ability in order to participate in
the study.
- Operable patients (ASA score =3)
Exclusion Criteria:
- Absolute indications for HR: infection/malunion/allergy to metal/refracture
- Ankle fractures that are not listed in the criteria above
- Patient treated for a fracture at the same foot/ ankle before
- Patient with fracture of two different regions of the foot/ankle
- Patient treated for the fracture outside of HFR and RHNe
- Patient non ambulating before time of injury
- Patients having diabete,
- immunocompromised under chemotherapy,
- Peripheral artery disease stade IV
- Pregnant patients
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
patient reported outcome after an ankle hardware removal
(ICTRP)
pain-related disability after an ankle hardware removal
complication rate after an ankle hardware removal surgery
(ICTRP)
Date d'enregistrement
22.03.2023 (ICTRP)
Inclusion du premier participant
01.05.2023 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
2023-00026 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05798741 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible