NCT03566082

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2009

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

August 1, 2023

Enrollment Period

12.4 years

First QC Date

January 10, 2018

Results QC Date

August 7, 2023

Last Update Submit

May 28, 2024

Conditions

Degenerative Joint Disease of Hip

Outcome Measures

Primary Outcomes (1)

  • Implant Survivorship

    Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').

    10 Years

Secondary Outcomes (2)

  • Modified Harris Hip Score (mHHS)

    Pre-operative, 3-years, 5-years, 7-years, 10-years

  • Number of Participants With Radiographic Success

    3-years, 5-years, 7-years 10-years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AZ Nikolaas

Sint-Niklaas, Belgium

Location

HUS Peijaksen sairaala, Ortopedia ja traumatologia

Helsinki, 00029, Finland

Location

TYKS Turku University Hospital

Turku, 20880, Finland

Location

La Paz Hospital

Madrid, 28046, Spain

Location

The Royal Orthopaedic Hospital, NHS Foundation Trust

Birmingham, B 31 2AP, United Kingdom

Location

Related Publications (1)

  • Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backle B, Revell MP, Kopjar B. Mid-term outcomes of the R3 delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.

    PMID: 33422084DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

At the 10+ Year interval, the follow-up rates that require collection of additional data for the secondary endpoints, ActualA-In-Window and ActualA, are 77.0% and 78.6%, respectively, for all hips. The additional analyses that were done to assess the impact of protocol deviations incurred including those resulting from the COVID-19 pandemic support that the missing data are unlikely to have an impact on the primary or secondary endpoint results.

Results Point of Contact

Title
Fleur Derdeyn, Principal Clinical Study Manager
Organization
Smith + Nephew
fleur.derdeyn@smith-nephew.com
0032 497 60 20 32

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

June 21, 2018

Study Start

May 28, 2009

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

May 30, 2024

Results First Posted

May 30, 2024

Record last verified: 2023-08

Locations

FI(2)ES(1)GB(1)BE(1)