| Registry | NCT07773402, acronym TPF |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 78 (Estimated) |
| Sponsor | Prof. Sajjad Hussain Goraya (Other) |
| Conditions | Tibial Plateau Fracture |
| Interventions | Hybrid Ilizarov Fixation, Locking Plate Fixation (Procedure) |
| Dates | start 2026-08-16 (estimated), primary completion 2026-11-16 (estimated), completion 2026-11-16 (estimated), first posted 2026-08-19, last updated 2026-08-19 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Tibial Plateau Fracture All trials of Hybrid Ilizarov Fixation All trials of Locking Plate Fixation
This comparative clinical study will evaluate and compare the functional outcomes of patients with Schatzker type V and VI tibial plateau fractures treated using either the locking plate technique or the hybrid Ilizarov technique. Functional outcome will primarily be assessed using the Rasmussen Knee Functional Score. Fracture healing, time to union, non-union, delayed union, and infection will also be assessed and compared between the two treatment groups.
Complex tibial plateau fractures, particularly Schatzker type V and VI fractures, are associated with substantial articular and metaphyseal injury and may present challenges in achieving satisfactory fracture reduction, stable fixation, soft-tissue preservation, and functional recovery.
The present comparative study will be conducted in the Orthopedic Department of Jinnah Hospital, Lahore. A total of 78 patients meeting the eligibility criteria will be recruited. Participants will be assigned to one of two treatment groups: Group A will undergo fixation using the hybrid Ilizarov technique, while Group B will undergo fixation using a locking plate technique.
Patients will undergo clinical and radiological assessment during follow-up. Functional outcome will be assessed using the Rasmussen Knee Functional Score. Radiographs will be obtained at regular follow-up intervals to evaluate fracture healing and union. Postoperative complications, including infection and non-union, will be documented.
The study will compare functional outcomes and fracture-healing outcomes between the two treatment techniques.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hybrid Ilizarov Technique | Experimental | Procedure: Hybrid Ilizarov Fixation | Patients with Schatzker type V or VI tibial plateau fractures will undergo fracture reduction and fixation using a hybrid Ilizarov external fixation technique. Closed or minimally open reduction will be performed under C-arm fluoroscopic guidance, followed by application of a hybrid Ilizarov frame using tensioned Kirschner wires and Schanz screws. Bone graft or bone substitute may be used when clinically indicated. |
| Locking Plate Technique | Active comparator | Procedure: Locking Plate Fixation | Patients with Schatzker type V or VI tibial plateau fractures will undergo fracture reduction and internal fixation using a locking compression plate under C-arm fluoroscopic guidance. Appropriate medial and/or lateral plate fixation will be performed according to fracture configuration and stability. Bone grafting may be used when clinically indicated. |
Sex: All, ages: 25 Years to 50 Years
Inclusion Criteria: * Patients of either sex. * Age between 25 and 50 years. * Patients presenting within 2 weeks of sustaining the fracture. * Patients diagnosed with complex tibial plateau fractures classified as Schatzker type V or VI. * Patients willing to participate in the study. * Patients providing written informed consent. Exclusion Criteria: * Associated ipsilateral limb fractures. * Pathological fracture of the tibia. * Associated major organ injuries. * Psychiatric illness that may interfere with participation or outcome assessment. * Refusal to provide informed consent.
| Facility | City | Country | Status |
|---|---|---|---|
| Jinnah Hospital Lahore | Lahore, Punjab Province | Pakistan | Recruiting |