NCT03327337

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

September 18, 2017

Last Update Submit

August 6, 2019

Conditions

ArthroscopyTibial FracturesOrthopedicFracture Fixation

Outcome Measures

Primary Outcomes (3)

  • Rasmussen scores change after surgery

    the knee joint Rasmussen scores change after surgery

    3、6、12 and 24 mouth Rasmussen scores change after surgery

  • Rasmunssen radiological evaluation 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

  • 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

    2 weeks and 1, 3, 6, 12, and 24 months postoperatively.

Secondary Outcomes (6)

  • Intraoperative blood loss

    Operation day

  • Surgical duration

    The day of the operation

  • VAS pain scores change after surgery

    from the day of the operation to the day of discharge from hospital (up to 2 weeks).

  • Hospitalization period after surgery

    The day of the operation to the day of discharge

  • 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.)

  • +1 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

operate with Arthroscopic Assisted Balloon Tibioplasty on this group patients

Procedure: Arthroscopic Assisted Balloon Tibioplasty

control group

OTHER

operate with open reduction and internal fixation on this group patients

Procedure: Arthroscopic Assisted Balloon Tibioplasty

Interventions

Arthroscopic Assisted Balloon TibioplastyPROCEDURE

Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation

control groupexperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients.
  • the patient signed the informed consent.

You may not qualify if:

  • Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30093519DERIVED

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

October 31, 2017

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 7, 2019

Record last verified: 2019-08