NCT02174965

Brief Summary

The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

10 years

First QC Date

August 1, 2013

Last Update Submit

June 24, 2014

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Radiostereometric Analysis (RSA) measured migration (mm)

    The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA.

    Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively

Secondary Outcomes (4)

  • Dynamically Inducible Micromotion DIMM (mm)

    Measured at 6, 12, 24 and 36 months post-operatively

  • Implant failure for femoral and acetabular components

    Observed at 3, 6, 12, 18, 24 and 36 months post-operatively

  • Change in Oxford Hip Score

    Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively

  • Change in Harris Hip Score

    Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively

Other Outcomes (1)

  • DEXA Scan

    Pre-operatively (baseline) and at 12 months post-operatively

Study Arms (2)

MiniHip (Corin U.K.)

EXPERIMENTAL

MiniHip (Corin U.K.) femoral component

Device: MiniHip (Corin U.K.)

Metafix (Corin, U.K)

ACTIVE COMPARATOR

Metafix (Corin, U.K) conventional cementless stem

Device: Metafix (Corin, U.K)

Interventions

MiniHip (Corin U.K.)DEVICE

MiniHip (Corin U.K.) femoral component

MiniHip (Corin U.K.)
Metafix (Corin, U.K)DEVICE

Metafix (Corin, U.K) conventional cementless stem

Metafix (Corin, U.K)

Eligibility Criteria

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

You may qualify if:

  • Women and men between the ages of 18 and 65 years old.
  • Scheduled to receive a hip replacement
  • Willing and able to give informed consent for participation in the study.
  • Diagnosed with hip osteoarthritis
  • Able (in the investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study

You may not qualify if:

  • The participants may not enter the study if ANY of the following apply:
  • Inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
  • Significant comorbidities that would make follow up difficult or uncomfortable
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk due to participation in the study, may influence the result of the study, or the participants ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuffield Orthopaedic Centre

Oxford, OX3 7LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sion Glyn-Jones, MA MBBS MRCS FRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Broomfield

CONTACT

john.broomfield@ndorms.ox.ac.uk

Alice Harin

CONTACT

alice.harin@ouh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

June 26, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

GB(1)