NCT03026868

Brief Summary

The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 15, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 12, 2017

Last Update Submit

December 13, 2017

Conditions

Fracture Dislocation

Keywords

acetabularquadrilateral surface plate

Outcome Measures

Primary Outcomes (1)

  • fracture healing time

    fracture line disappeared in the radiograph

    4 months

Secondary Outcomes (1)

  • complication

    1 month

Study Arms (1)

quadrilateral surface plate

EXPERIMENTAL

The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.

Procedure: quadrilateral surface plate

Interventions

quadrilateral surface platePROCEDURE

Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.

quadrilateral surface plate

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old
  • Fracture involving quadrilateral surface
  • Operation was conducted within 14 days
  • Fixed with quadrilateral surface plate through Stoppa approach

You may not qualify if:

  • Presented with a pathologic acetabular fracture
  • Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
  • Refused to participate
  • Follow-up insufficient 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiyong Hou

Shijiazhuang, Hebei, 050051, China

RECRUITING

MeSH Terms

Conditions

Fracture Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesFractures, Bone

Study Officials

  • Ruipeng Zhang, M.D

    Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Hou, M.D

CONTACT

+8618533112800houzhiyong1234@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 20, 2017

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

December 15, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)