Treatment of Tibial Plateau Fractures With Bone-graft and Bone Tamp Technique
- Conditions
- Depressed Tibial Plateau Fractures
- Interventions
- Procedure: surgery
- Registration Number
- NCT04807062
- Lead Sponsor
- Hebei Medical University Third Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DTPFs treated with structural bicortical autologous ICBG combined with TBTM surgery -
- Primary Outcome Measures
Name Time Method Postoperative immediate reduction rate up to 2 weeks 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.
Postoperative long-term reduction rate up to 2 weeks 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.
Bone healing time up to 2 weeks 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.
- Secondary Outcome Measures
Name Time Method intraoperative blood loss up to 1 weeks 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.
The incidence of complications in the bone-graft donor and bone-graft sites up to 1 weeks Surging-related complications of all subjects were recorded as a basis for evaluating surgical outcomes.
Hospital for Special Surgery score of knee uo to 1 week 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.
operative time up to 1 weeks 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.
the Visual Analog Scale scores of ICBG donor and bone-graft sites up to 1 week 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.
36-Item Short-Form Health Survey score up to 1 week 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.
Trial Locations
- Locations (1)
the Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China