Pilon Fracture Clinical Trial
Official title:
Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial
Verified date | April 2024 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 1, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Skeletally mature patients - Both males and females - Closed or open (grade 1&2) pilon fractures according to Gustilo and Anderson classification - AO/OTA type C fractures - Compromised soft tissue not allowing for primary open reduction and internal fixation - Unilateral or bilateral - Isolated or polytrauma patients Exclusion Criteria: - Skeletally immature patients - Open grade 3 pilon fractures - Patients eligible for primary open reduction and internal fixation - Ipsilateral lower limb fractures - Pathological fractures - Pre-existing symptomatic ankle arthritis |
Country | Name | City | State |
---|---|---|---|
Egypt | El-Demerdash hospital Ain shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40. — View Citation
Michelson J, Moskovitz P, Labropoulos P. The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307. — View Citation
Ruedi TP, Allgower M. The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional | Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system.
The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items Activity limitations, support requirements (10points) Maximum walking distance, blocks (5 points) Walking surfaces (5 points) Gait abnormality (8 points) Sagittal motion (flexion plus extension) (8points) Hindfoot motion (inversion plus eversion) (6points) Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points) |
12 months | |
Primary | Radiological | Accuracy of reduction in plain x Ray using burwell& charnely score It includes Anatomical reduction , fair reduction & poor reduction
Anatomical... No medial or lateral displacement of the medial & lateral malleulus no angulation no more than 1 ml of longitudinal displacement of the medial or lateral malleli no more then 2 ml of proximal displacement of a large posterior fragment no talus displacement Fair ... No medial or lateral displacement of the medial & lateral malleulus no angulation 2-5 ml of posterior displacement of lateral malleulus 2-5 ml of proximal displacement of a large posterior fragment no talus displacement Poor ... Any medial or lateral displacement of the medial & lateral malleulus no angulation more than 5 ml of posterior displacement of lateral malleulus more than 5 ml of proximal displacement of a large posterior fragment any residual talus displacement |
12 months |
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