NCT02566694

Brief Summary

The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

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

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

September 30, 2015

Last Update Submit

April 11, 2017

Conditions

Implants

Outcome Measures

Primary Outcomes (1)

  • Cause of failure

    At time of failure which is likely to be an average of 5 years post operative

Study Arms (2)

Failed implants

All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

Procedure: Implant

Controls with different failure modes

We will compare findings with different types of orthopaedic implants and categories of failure mode.

Procedure: Implant

Interventions

ImplantPROCEDURE

orthopaedic implant

Controls with different failure modesFailed implants

Eligibility Criteria

Age11 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be both male and female, aged between 11-70 years.

You may qualify if:

  • All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

You may not qualify if:

  • Patients not consenting to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, London, HA7 4LP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Periprosthetic tissue samples

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Alister Hart, FRCSG(Orth)

    RNOH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iva Hauptmannova, BSc

CONTACT

Iva.Hauptmannova@rnoh.nhs.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedics

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2020

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

GB(1)