Ablation of osteosynthesis material after ankle osteosynthesis: a randomized study.
Descrizione riassuntiva dello studio
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)
Intervento studiato
The ablation of osteosynthesis material, that is, the surgical procedure aimed at removing the plates and screws, after surgery for an ankle fracture.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
-absolute indications for ablation of osteosynthesis material: infection, non-union, metal allergy, refracture -FAAM score <5% or >95% -history of ankle fracture (BASEC)
Luogo dello studio
Friburgo, Neuchâtel
(BASEC)
Sponsor
HFR Fribourg
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Angela Seidel
+41 26 306 28 02
Angela.Seidel@clutterh-fr.chHFR Fribourg
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
31.08.2023
(BASEC)
ID di studio ICTRP
NCT05798741 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Hardware Removal after ORIF of ankle fractures: A randomized trial (BASEC)
Titolo accademico
Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial (ICTRP)
Titolo pubblico
Hardware Removal After ORIF of Ankle Fractures (ICTRP)
Malattie studiate
Ankle Fractures
(ICTRP)
Intervento studiato
Procedure: Hardware removal
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
22.03.2023 (ICTRP)
Inclusione del primo partecipante
01.05.2023 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
2023-00026 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05798741 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile