MASTER SL Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Requiring Hip Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MASTER SL

MASTER SL femoral stem and DELTA TT acetabular cup

Intervention Type DEVICE

Interventions

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MASTER SL femoral stem and DELTA TT acetabular cup

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No