A Phase 4 interventional study of Pinnacle Acetabular System in Rheumatoid Arthritis, Osteoarthritis and Post-traumatic Arthritis, sponsored by DePuy International. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by DePuy International (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
Among 13 studies in Arthritis, Rheumatoid by DePuy International — none open to participants now, none under way, none of them phase 3. Arthritis, Rheumatoid · DePuy International.
Among the 13 studies in Arthritis, Rheumatoid by DePuy International, this one is the 13th largest by enrollment, is one of 2 that started in 2004, is one of 12 in phase 4, and was the 1st registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →None of the 13 studies in Arthritis, Rheumatoid by DePuy International is open now.
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2004.
Median enrollment 163 across the 13 interventional studies. Of the 12 that completed or were terminated, 0 (0%) have results posted.
DePuy International is the lead sponsor of 42 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Arthritis, Rheumatoid by DePuy International, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i) Male or female subjects, aged between 18 and 70 years inclusive.
ii) Subjects who are able to give voluntary, written to participate in this investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
ii) Subjects undergoing revision hip replacement.
iii) Subjects undergoing simultaneous bilateral hip operation.
iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
v) Women who are pregnant.
vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
vii) Subjects who have participated in a clinical study with an product in the last 12 months.
viii) Subjects who are currently involved in any injury litigation claims.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Pinnacle Acetabular System
Kaplan-Meier survivorship calculated at the five-year time-point.
Time frame: 5 yrs post surgery
Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score
Time frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score
Time frame: Annually up to 15 yrs post-surgery
Kaplan-Meier survivorship
Time frame: Annually up to 15 yrs post-surgery
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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