Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures (AABTFTPF)
Primary Purpose
Arthroscopy, Tibial Fractures, Orthopedic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arthroscopic Assisted Balloon Tibioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Arthroscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental group
control group
Arm Description
operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients
operate with open reduction and internal fixation on this group patients
Outcomes
Primary Outcome Measures
Rasmussen scores change after surgery
the knee joint Rasmussen scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
Rasmunssen radiological evaluation scores change after surgery
The quality of reduction
The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression
Secondary Outcome Measures
Intraoperative blood loss
blood loss in surgery
Surgical duration
Surgical duration
VAS pain scores change after surgery
The severity of lower limb pain after surgery
Hospitalization period after surgery
Hospitalization period after surgery
Complications
Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded.
the Short-Form Health Survey (SF-36) questionnaire
Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up.
Full Information
NCT ID
NCT03327337
First Posted
September 18, 2017
Last Updated
August 6, 2019
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03327337
Brief Title
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
Acronym
AABTFTPF
Official Title
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroscopy, Tibial Fractures, Orthopedic, Fracture Fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients
Arm Title
control group
Arm Type
Other
Arm Description
operate with open reduction and internal fixation on this group patients
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Assisted Balloon Tibioplasty
Intervention Description
Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
Primary Outcome Measure Information:
Title
Rasmussen scores change after surgery
Description
the knee joint Rasmussen scores change after surgery
Time Frame
3、6、12 and 24 mouth Rasmussen scores change after surgery
Title
Rasmunssen radiological evaluation scores change after surgery
Description
Rasmunssen radiological evaluation scores change after surgery
Time Frame
immediately, and at 2 weeks and 1, 3, 6, 12, and 24 months Rasmunssen radiological evaluation scores change after surgery
Title
The quality of reduction
Description
The quality of reduction will be determined based on postoperative CT scans, which can directly measure the amount of residual depression
Time Frame
2 weeks and 1, 3, 6, 12, and 24 months postoperatively.
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
blood loss in surgery
Time Frame
Operation day
Title
Surgical duration
Description
Surgical duration
Time Frame
The day of the operation
Title
VAS pain scores change after surgery
Description
The severity of lower limb pain after surgery
Time Frame
from the day of the operation to the day of discharge from hospital (up to 2 weeks).
Title
Hospitalization period after surgery
Description
Hospitalization period after surgery
Time Frame
The day of the operation to the day of discharge
Title
Complications
Description
Complications including wound infection, reoperations, and posttraumatic arthritis (PTA) will be recorded.
Time Frame
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.)
Title
the Short-Form Health Survey (SF-36) questionnaire
Description
Health-related quality of life will be measured using the Short-Form Health Survey (SF-36) questionnaire during follow-up.
Time Frame
1, 3, 6, 12, and 24 months follow-up time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30093519
Citation
Wang JQ, Jiang BJ, Guo WJ, Zhang WJ, Li AB, Zhao YM. Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II-IV tibial plateau fractures: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 8;8(8):e021667. doi: 10.1136/bmjopen-2018-021667.
Results Reference
derived
Learn more about this trial
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures
We'll reach out to this number within 24 hrs