Clinical trial NCT01383824: A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
Official title: A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Arthritis
Secondary Arthritis
Keywords: Hip Replacement
Femoral Component
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 89
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria: Inclusion Criteria:

* Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Primary outcomes:
measure: Kaplan-Meier survivorship
timeFrame: 5 years post-surgery
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: 6 weeks-6 mths
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 6 weeks-6 mths
measure: EuroQol EQ-5D
timeFrame: 6 weeks-6 mths
measure: Harris Hip Score
timeFrame: 6 weeks-6 mths
measure: Radiographic analysis
timeFrame: pre-discharge
measure: Oxford Hip Score
timeFrame: 2 years
measure: Oxford Hip Score
timeFrame: 3 years
measure: Oxford Hip Score
timeFrame: 4 Years
measure: Oxford Hip Score
timeFrame: 5 years
measure: Oxford Hip Score
timeFrame: 6 Years
measure: Oxford Hip Score
timeFrame: 7 Years
measure: Oxford Hip Score
timeFrame: 8 Years
measure: Oxford Hip Score
timeFrame: 9 years
measure: Oxford Hip Score
timeFrame: 10 Years
measure: Oxford Hip Score
timeFrame: 11 Years
measure: Oxford Hip Score
timeFrame: 12 Years
measure: Oxford Hip Score
timeFrame: 13 Years
measure: Oxford Hip Score
timeFrame: 14 Years
measure: Oxford Hip Score
timeFrame: 15 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 2 years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 3 years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 4 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 5 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 6 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 7 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 8 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 9 years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 10 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 11 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 12 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 13 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 14 Years
measure: University of California Los Angeles (UCLA) Activity Score
timeFrame: 15 years
measure: EuroQol EQ-5D
timeFrame: 2 Years
measure: EuroQol EQ-5D
timeFrame: 3 Years
measure: EuroQol EQ-5D
timeFrame: 4 Years
measure: EuroQol EQ-5D
timeFrame: 5 Years
measure: EuroQol EQ-5D
timeFrame: 6 years
measure: EuroQol EQ-5D
timeFrame: 7 years
measure: EuroQol EQ-5D
timeFrame: 8 Years
measure: EuroQol EQ-5D
timeFrame: 9 Years
measure: EuroQol EQ-5D
timeFrame: 10 Years
measure: EuroQol EQ-5D
timeFrame: 11 Years
measure: EuroQol EQ-5D
timeFrame: 12 Years
measure: EuroQol EQ-5D
timeFrame: 13 Years
measure: EuroQol EQ-5D
timeFrame: 14 Years
measure: EuroQol EQ-5D
timeFrame: 15 Years
measure: Harris Hip Score
timeFrame: 2 Years
measure: Harris Hip Score
timeFrame: 5 Years
measure: Harris Hip Score
timeFrame: 10 Years
measure: Harris Hip Score
timeFrame: 15 Years
measure: Radiographic analysis
timeFrame: 6 weeks - 6 mths
measure: Radiographic analysis
timeFrame: 1 year
measure: Radiographic analysis
timeFrame: 2 Years
measure: Radiographic analysis
timeFrame: 5 Years
measure: Radiographic analysis
timeFrame: 10 years
measure: Radiographic analysis
timeFrame: 15 Years
Other outcomes:
Locations:
city: Sønderborg
country: Denmark
facility: Sygehus Sønderjyllands
city: Speyer
country: Germany
facility: Orthopädie Kupfalz
city: Rome
country: Italy
facility: Orthopaedic Clinic University La Sapienza
city: Sevilla
country: Spain
facility: Hospital Nisa Sevilla-Aljarafe
city: Sevilla
country: Spain
facility: Hospital San Juan de Dios del Aljarafe
city: Sevilla
country: Spain
facility: Hospital Santa Ángela De La Cruz
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
state: Essex
city: Sawbridgeworth
country: United Kingdom
facility: The Rivers Hospital
state: Hertfordshire
city: Wrightington
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
Study officials:
References: