Treatment of Tibial Plateau Fractures With Bone-graft and Bone Tamp Technique

Study Overview
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Brief Summary
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Autologous ICBG and bone tamp methods are often applied to manage depressed tibial plateau fracture (DTPF), but previous iliac bone harvesting and bone tamp techniques remain controversial. The purpose of this study is to describe and evaluate the technique of using structural bicortical autologous iliac crest bone-graft (ICBG) combined with tunnel bone tamps method (TBTM) in treating DTPFs.

Official Title
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Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures

Conditions
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Depressed Tibial Plateau Fractures

Intervention / Treatment
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* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (age ≥ 18 years); diagnosis of DTPFs; agreeing to receive structural bicortical autologous ICBG combined with TBTM treatment and subsequent internal fixation treatment; agreeing to participate in regular follow-up after surgery. Exclusion Criteria: open fracture; pathologic fractures; bone metabolic disease; previous ICBG; infection or soft tissue injury of the iliac bone donor site; pelvic fractures or bone tumors; associated peripheral nerve injury; non-completion of 30 months follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTPFs treated with structural bicortical autologous ICBG combined with TBTM<br> | Procedure: surgery<br>* tunnel bone tamps method (TBTM) was used to reduce the depressed articular fragments and then structural bicortical autologous ICBG was used to fill the valley tunnel.<br>* Other names: Structural bicortical autologous iliac crest bone graft combined with tunnel bone tamps method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative immediate reduction rate | Preoperative and postoperative imaging data of all subjects, including X-ray and CT scans, were collected. Picture Archiving and Communication Systems (PACS) was used to measure articular step-off and evaluate the immediate reduction after surgery. | up to 2 weeks | 
| Postoperative long-term reduction rate | The immediate postoperative and follow-up imaging data of all subjects, including X-ray and CT scan, were collected. PACS system was used to measure the articular step-off and evaluate the long-term reduction after surgery. | up to 2 weeks | 
| Bone healing time | Postoperative follow-up imaging data of all patients were collected, including X-ray and CT scans.Evaluating the bone healing time based on callus growth. | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | The operation time in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma. | up to 1 weeks | 
| intraoperative blood loss | The intraoperative blood loss in the bone graft donor site and bone graft site of all subjects was recorded as the basis for evaluating the size of surgical trauma. | up to 1 weeks | 
| The incidence of complications in the bone-graft donor and bone-graft sites | Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes. | up to 1 weeks | 
| the Visual Analog Scale scores of ICBG donor and bone-graft sites | The Visual Analog Scale pain scores (ranged from 0 to 10, 0 representing no pain and 10 representing maximal imaginable pain) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect. | up to 1 week | 
| Hospital for Special Surgery score of knee | The knee Hospital for Special Surgery scores (ranged from 0 to 100, 0 representing poor knee function and 100 representing normal knee function) of all subjects during the postoperative follow-up was recorded as the basis for evaluating the surgical effect. | uo to 1 week | 
| 36-Item Short-Form Health Survey score | 36-Item Short-Form Health Survey scores (ranged from 0 to 100, 0 representing poor health and 100 representing normal health) of all subjects during postoperative follow-up were recorded as the basis for evaluating the surgical effect. | up to 1 week |