Clinical trial NCT02174965: Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene
Official title: RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Corin
name: Oxford University Hospitals NHS Trust
First posted: 2014-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Radiostereometric Analysis (RSA) measured migration (mm)
timeFrame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Secondary outcomes:
measure: Dynamically Inducible Micromotion DIMM (mm)
timeFrame: Measured at 6, 12, 24 and 36 months post-operatively
measure: Implant failure for femoral and acetabular components
timeFrame: Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
measure: Change in Oxford Hip Score
timeFrame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
measure: Change in Harris Hip Score
timeFrame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Other outcomes:
measure: DEXA Scan
timeFrame: Pre-operatively (baseline) and at 12 months post-operatively
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
Study officials:
affiliation: University of Oxford
name: Sion Glyn-Jones, MA MBBS MRCS FRCS
role: PRINCIPAL_INVESTIGATOR
References: