Ablation of osteosynthesis material after ankle osteosynthesis: a randomized study.
Summary description of the study
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 under investigation
The ablation of osteosynthesis material, that is, the surgical procedure aimed at removing the plates and screws, after surgery for an ankle fracture.
(BASEC)
Disease under 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)
Exclusion criteria
-absolute indications for ablation of osteosynthesis material: infection, non-union, metal allergy, refracture -FAAM score <5% or >95% -history of ankle fracture (BASEC)
Trial sites
Freiburg, Neuchatel
(BASEC)
Sponsor
HFR Fribourg
(BASEC)
Contact
Contact Person Switzerland
Angela Seidel
+41 26 306 28 02
Angela.Seidel@clutterh-fr.chHFR Fribourg
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
31.08.2023
(BASEC)
ICTRP Trial ID
NCT05798741 (ICTRP)
Official title (approved by ethics committee)
Hardware Removal after ORIF of ankle fractures: A randomized trial (BASEC)
Academic title
Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial (ICTRP)
Public title
Hardware Removal After ORIF of Ankle Fractures (ICTRP)
Disease under investigation
Ankle Fractures
(ICTRP)
Intervention under investigation
Procedure: Hardware removal
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
22.03.2023 (ICTRP)
Incorporation of the first participant
01.05.2023 (ICTRP)
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
2023-00026 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05798741 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available