NCT03060655

Brief Summary

The different proportion samples of PLGA-Mg were made in this study. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to fix the fragments. Then, the clinical role for bone will be assessed.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

January 18, 2017

Last Update Submit

February 21, 2017

Conditions

Fracture Dislocation

Keywords

PLGA-Mgfracturefixationunion

Outcome Measures

Primary Outcomes (1)

  • fracture union time

    4 months

Secondary Outcomes (1)

  • complication

    1 months

Study Arms (2)

PLGA-Mg material

PLACEBO COMPARATOR

The fixation of fragments of study group was accomplished with PLGA-Mg material.

Biological: PLGA-Mg material

titanium alloy

PLACEBO COMPARATOR

The fixation of fragments of control group was accomplished with titanium alloy material.

Biological: titanium alloy

Interventions

PLGA-Mg materialBIOLOGICAL

The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.

PLGA-Mg material
titanium alloyBIOLOGICAL

Traditional fixation was titanium alloy. the clinical outcome was assessed.

titanium alloy

Eligibility Criteria

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

You may qualify if:

  • years old
  • Closed fracture
  • Sign the agreement of the experiment

You may not qualify if:

  • Pathologic fracture
  • Open fracture
  • Refused to participate
  • Follow-up insufficient 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050051, China

RECRUITING

MeSH Terms

Conditions

Fracture DislocationFractures, Bone

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • Ruipeng Zhang, M.D

    Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingze Zhang, M.D

CONTACT

+8613313012888yzzhangdr@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

February 23, 2017

Study Start

August 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

February 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)