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Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe (R3 EU PAS)

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ClinicalTrials.gov Identifier: NCT03566082
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
eResearchTechnology, Inc
NAMSA Medvance
M Squared Associates,Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )

Brief Summary:
The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Condition or disease
Degenerative Joint Disease of Hip

Detailed Description:

This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease").

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.


Study Type : Observational
Actual Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Post Approval Study

The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively.

The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure.




Primary Outcome Measures :
  1. Implant survivor rate [ Time Frame: 10 Years ]
    Did hip survive with no revision through 10 years


Secondary Outcome Measures :
  1. Modified Harris Hip Score [ Time Frame: 10 Years ]
    Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points

  2. Radiographic outcomes [ Time Frame: 10 Years ]

    radiographic success defined as:

    • No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and
    • No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and
    • No acetabular cup inclination changes greater than 4 degrees (4°)

  3. Adverse Events [ Time Frame: 10 Years ]
    All AEs will be collected and reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable.
Criteria

Inclusion Criteria:

Patient is 18-75 years old and he/she is skeletally mature

  • Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip) or inflammatory joint disease (e.g., rheumatoid arthritis)
  • Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
  • The patient is willing to comply the follow-up schedule

Exclusion Criteria:

Patient has active infection or sepsis (treated or untreated)

  • Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse,
  • Patients with acute hip trauma (femoral neck fracture)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566082


Locations
Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
Finland
HUS Peijaksen sairaala, Ortopedia ja traumatologia
Helsinki, Finland, 00029
TYKS Turku University Hospital
Turku, Finland, 20880
Spain
La Paz Hospital
Madrid, Spain, 28046
United Kingdom
The Royal Orthopaedic Hospital, NHS Foundation Trust
Birmingham, United Kingdom, B 31 2AP
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
eResearchTechnology, Inc
NAMSA Medvance
M Squared Associates,Inc.

Responsible Party: Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier: NCT03566082     History of Changes
Other Study ID Numbers: R11019
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Hip
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases