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

Hip Osteoarthritis Clinical Trial

— MiniHip  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02174965
• Other study ID #: MiniHip
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2013
• Last updated: June 24, 2014
• Start date: September 2012
• Est. completion date: September 2022

Study information

• Verified date: June 2014
• Source: University of Oxford
• Contact: John Broomfield
• Email: john.broomfield[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• MiniHip (Corin U.K.)
MiniHip (Corin U.K.) femoral component
• Metafix (Corin, U.K)
Metafix (Corin, U.K) conventional cementless stem

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Corin, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DEXA Scan	To monitor for peri-prosthetic changes in bone density following surgery	Pre-operatively (baseline) and at 12 months post-operatively	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No