MASTER SL Clinical Study

Limacorporate

Status: Unknown

Conditions: Patients Requiring Hip Replacement

Treatments: Device: MASTER SL femoral stem and DELTA TT acetabular cup

Study type: Observational

Funder types: Industry

Identifiers

NCT02126345

H-14

Details and patient eligibility

About

The purpose of this study is:

• to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
• to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
• to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female ≥18 years;
• Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
• Life expectancy of >10 years;
• Voluntary written Informed Consent obtained.

Exclusion criteria

• Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
• Requiring revision hip replacement;
• Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
• Previous organ transplant;
• Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
• Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
• Body mass index (kg/m2) exceeds 40;
• Active or suspected infection;
• Known sensitivity to device materials;
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.

Trial design

150 participants in 1 patient group

MASTER SL

Treatment:

Device: MASTER SL femoral stem and DELTA TT acetabular cup