Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene (MiniHip)

RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: MiniHip (Corin U.K.); Device: Metafix (Corin, U.K)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Broomfield; Email: john.broomfield@ndorms.ox.ac.uk
• Study Contact Backup: Name: Alice Harin; Email: alice.harin@ouh.nhs.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LD
    • Recruiting
    • Nuffield Orthopaedic Centre
    • Contact: John Broomfield; Email: john.broomfield@ndorms.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiniHip (Corin U.K.); MiniHip (Corin U.K.) femoral component	Device: MiniHip (Corin U.K.); MiniHip (Corin U.K.) femoral component
Active Comparator: Metafix (Corin, U.K); Metafix (Corin, U.K) conventional cementless stem	Device: Metafix (Corin, U.K); Metafix (Corin, U.K) conventional cementless stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamically Inducible Micromotion DIMM (mm)	Using RSA this compares standard images with images taken in a single leg stance.	Measured at 6, 12, 24 and 36 months post-operatively
Implant failure for femoral and acetabular components	Follow up assessment will monitor for signs of implant failure.	Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Oxford Hip Score	A PROM to assess patient benefit.	Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Harris Hip Score	A clinician recorded outcome score to assess functional improvement.	Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEXA Scan	To monitor for peri-prosthetic changes in bone density following surgery	Pre-operatively (baseline) and at 12 months post-operatively

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Oxford University Hospitals NHS Trust; Corin
• Investigators: Principal Investigator: Sion Glyn-Jones, MA MBBS MRCS FRCS, University of Oxford

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: MiniHip