NCT02981823

Brief Summary

To provide information on reducing the incidence of periprosthetic fractures during hip replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic fractures and their effects on hip functional recovery.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

November 24, 2016

Last Update Submit

December 1, 2016

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Harris hip scores

    To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor \<70 points. The higher score indicates the better function of the hip.

    Changes of baseline and 6 months after operation

Secondary Outcomes (1)

  • X-ray image

    Changes of baseline and month 6, month 12, month 24 after operation

Study Arms (1)

hip replacement

EXPERIMENTAL

The patients undergo total hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.

Procedure: hip replacement

Interventions

hip replacementPROCEDURE

The patients undergo hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.

hip replacement

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnostic and staging criteria in line with the Expert consensus on diagnosis and treatment of adult femoral head necrosis
  • Femoral head necrosis of Association Research Circulation Osseous (ARCO) stages III-IV
  • Unilateral femoral head necrosis
  • Age \< 50 years
  • Both genders

You may not qualify if:

  • Advanced osteoarthritis
  • Secondary osteoarthritis due to acetabular dysplasia
  • Ankylosing spondylitis involving the hip joint
  • Rheumatoid arthritis
  • Inflammatory inflammation of the hip joint
  • Tumor lesions in the hip joint
  • Unable or refusal to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Di Qin, Ph.D

    Hebei Medical University Third Hospital

    PRINCIPAL INVESTIGATOR

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

November 24, 2016

First Posted

December 5, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

December 5, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share