Ablation of osteosynthesis material after ankle osteosynthesis: a randomized study.
Zusammenfassung der Studie
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)
Untersuchte Intervention
The ablation of osteosynthesis material, that is, the surgical procedure aimed at removing the plates and screws, after surgery for an ankle fracture.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
-absolute indications for ablation of osteosynthesis material: infection, non-union, metal allergy, refracture -FAAM score <5% or >95% -history of ankle fracture (BASEC)
Studienstandort
Freiburg, Neuenburg
(BASEC)
Sponsor
HFR Fribourg
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Angela Seidel
+41 26 306 28 02
Angela.Seidel@clutterh-fr.chHFR Fribourg
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.08.2023
(BASEC)
ICTRP Studien-ID
NCT05798741 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Hardware Removal after ORIF of ankle fractures: A randomized trial (BASEC)
Wissenschaftlicher Titel
Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial (ICTRP)
Öffentlicher Titel
Hardware Removal After ORIF of Ankle Fractures (ICTRP)
Untersuchte Krankheit(en)
Ankle Fractures
(ICTRP)
Untersuchte Intervention
Procedure: Hardware removal
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
22.03.2023 (ICTRP)
Einschluss des ersten Teilnehmers
01.05.2023 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
2023-00026 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05798741 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar