MASTER SL Clinical Study

A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02126345

Enrollment

150

Registered

2014-04-30

Start date

2014-05-31

Completion date

2023-12-31

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Hip Replacement

Brief summary

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.

Interventions

DEVICEMASTER SL femoral stem and DELTA TT acetabular cup

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Rate of failure	3 years

Secondary

Measure	Time frame
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L	from baseline to all time-points

Other

Measure	Time frame
Any undesirable side effects	3 and 5 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026