Arthroscopy, Fracture Fixation, Orthopedic, Tibial Fractures
Conditions
Brief summary
The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
Detailed description
The Balloon Tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.
Interventions
PROCEDUREArthroscopic Assisted Balloon Tibioplasty
Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients. * the patient signed the informed consent.
Exclusion criteria
* Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rasmussen scores change after surgery | 3、6、12 and 24 mouth Rasmussen scores change after surgery | the knee joint Rasmussen scores change after surgery |
| Rasmunssen radiological evaluation scores change after surgery | immediately, and at 2 weeks and 1, 3, 6, 12, and 24 months Rasmunssen radiological evaluation scores change after surgery | Rasmunssen radiological evaluation scores change after surgery |
| The quality of reduction | 2 weeks and 1, 3, 6, 12, and 24 months postoperatively. | The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization period after surgery | The day of the operation to the day of discharge | Hospitalization period after surgery |
| Intraoperative blood loss | Operation day | blood loss in surgery |
| the Short-Form Health Survey (SF-36) questionnaire | 1, 3, 6, 12, and 24 months follow-up time | Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up. |
| Complications | 1, 3, 6, 12, and 24 months follow-up time. (PTA may not be seen in patients within the 24-month follow-up period, and we will perform follow-up for at least 10 years in all patients.) | Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded. |
| Surgical duration | The day of the operation | Surgical duration |
| VAS pain scores change after surgery | from the day of the operation to the day of discharge from hospital (up to 2 weeks). | The severity of lower limb pain after surgery |
Outcome results
None listed