A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

NCT00208429 | Withdrawn Phase 4

• 1 other identifier: CT03/40
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Keywords

Hip; Cementless

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship calculated at the five-year time-point.

  5 yrs post surgery

Secondary Outcomes (3)

• Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score

  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

  Annually up to 15 yrs post-surgery

• Kaplan-Meier survivorship

  Annually up to 15 yrs post-surgery

Study Arms (1)

Pinnacle Acetabular System

OTHER

Device: Pinnacle Acetabular System

Interventions

Pinnacle Acetabular System DEVICE

Pinnacle Acetabular System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) Male or female subjects, aged between 18 and 70 years inclusive.
• ii) Subjects who are able to give voluntary, written informed consent 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 investigational 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.

You may not qualify if:

• 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 investigational product in the last 12 months.
• viii) Subjects who are currently involved in any injury litigation claims.

Sponsors & Collaborators

• DePuy International: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2019
• Last Updated: June 28, 2017

Record last verified: 2017-06