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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
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 18, 2017
    Last Updated
    August 6, 2019
    Sponsor
    Second Affiliated Hospital of Wenzhou Medical University
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    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

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