Have you or your loved ones been diagnosed with hip osteoarthritis?

You may be eligible to participate in a hip osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with hip osteoarthritis? You may be eligible to participate in a hip osteoarthritis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Hip Osteoarthritis Clinical Trial in Oxford

NCT02174965 | Interventional

Have you or your loved ones been diagnosed with hip osteoarthritis?

You may be eligible to participate in a hip osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with hip osteoarthritis? You may be eligible to participate in a hip osteoarthritis clinical trial.

Recruiting

Male & Female

18 - 65

Years old

This study is looking to recruit 50 Participants

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.

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Details for the study

Brief Title

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.

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.

Treatments and/or Procedures

Metafix corin U k

Metafix (Corin, U.K) conventional cementless stem

Mini hip corin U k

MiniHip (Corin U.K.) femoral component

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

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

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

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

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

Other

DEXA Scan

To monitor for peri-prosthetic changes in bone density following surgery

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

Study 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.