- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07773402
Comparison of Functional Outcome Between Locking Plate Technique Versus Hybrid Ilizarov Technique in Patients With Schatzker Type V and VI Tibial Plateau Fractures (TPF)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Montiha Azeem
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
Study Contact Backup
- Name: Sajjad Hussain
- Phone Number: 0333 4077389
- Email: prof.sajjadhussain@aimc.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Jinnah Hospital Lahore
-
Contact:
- Sajjad Hussain
- Phone Number: 0333 4077389
- Email: muntahaazeem9@gmail.com
-
Contact:
- Montiha Azeem
- Email: muntahaazeem9@gmail.com
-
Principal Investigator:
- Sajjad Hussain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hybrid Ilizarov Technique
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.
|
Patients with Schatzker type V or VI tibial plateau fractures will undergo fracture reduction and fixation using a hybrid Ilizarov external fixation system under C-arm fluoroscopic guidance.
Closed or minimally open reduction will be performed as appropriate.
The construct will consist of a hybrid Ilizarov C-ring with appropriately tensioned Kirschner wires and Schanz screws.
Additional wires or fixation components may be used when required to achieve adequate fracture stability and alignment.
Bone graft or bone substitute may be used when clinically indicated.
|
|
Active Comparator: Locking Plate Technique
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.
|
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.
The appropriate surgical approach and medial and/or lateral plate configuration will be selected according to fracture morphology, comminution, and stability.
Bone graft or bone substitute may be used when clinically indicated.
Postoperative rehabilitation will include early knee range-of-motion exercises, non-weight-bearing ambulation initially, and progressive weight-bearing according to clinical and radiological fracture healing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rasmussen Knee Functional Score
Time Frame: 8 weeks and 16 weeks
|
Functional outcome will be assessed using the Rasmussen Knee Functional Score at the final postoperative assessment.
Scores will be categorized as excellent (27-30), good (20-26), fair (10-19), or poor (6-9).
The score will be compared between patients treated with hybrid Ilizarov fixation and those treated with locking plate fixation.
|
8 weeks and 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERB196/4/06-11-2025/AIMC/JHL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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