A prospective Radiostereometric Analysis (RSA) study of the cemented Total Hip System (E2 stem/ P2 cup) in patients with degenerative hip disease

Not Applicable

• Conditions: Musculoskeletal - Osteoarthritis; Degenerative hip disease

• Registration Number: ACTRN12610000853044
• Lead Sponsor: Joint Research Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.Patient requires unilateral primary total hip arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip (DDH) who are candidates for a Cemented Total Hip System as determined jointly by the surgeon and patient.

2.Male and non-pregnant female patients aged 18 to 75

3.Patients who understand the conditions of the study and are willing and able to give written informed consent to participate in the length of the study including prescribed follow-ups.

Exclusion Criteria

1.Patient has active infection or sepsis (treated or untreated)

2.Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.

3.Patient is female of child-bearing age and not taking contraceptive precautions

4.Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis).

5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis)

6.Patient has known moderate to severe renal insufficiency.

7.Patient has a known or suspected metal sensitivity.

8.Patient is immunosuppressed with diseases such as acquired immunodeficiency syndrome (AIDS) or receiving high doses of corticosteroids.

9.Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the Clinical Evaluation including mental illness, mental retardation, or drug, alcohol abuse.

10.Patient is severely overweight. Body Mass Index BMI > 40.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the migration of the E2 Cemented femoral stem and the P2 all-poly cup, in primary cemented total hip replacement using an RSA technique to predict long-term safety and effectiveness of each hip system component from early post operative outcomes in a small cohort of patients.[Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery];To evaluate the in-vivo wear of the P2 cup, in primary cemented total hip replacement using an RSA technique to determine polyethylene wear rates per annum in 3 directions.[Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery]

Secondary Outcome Measures

Name	Time	Method
To estimate the clinical complication rates for the Cemented E2 Total Hip System using clinical evaluations for disease specific scores (Oxford Hip Score) and non-disease specific scores Hip Dysfunction and Oestoarthritis Outcome Score(HOOS) in addition to collation of any adverse events including clinical and radiological underperformance.[Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery]