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Completed

NCT Number: NCT00306930

Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

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Key information

Conditions

Osteoarthritis Acute Fracture Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DePuy Orthopaedics

Warsaw, Indiana, 46581, United States

About this study

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary hip replacement
  • Sufficient bone stock to support implant
  • Signed Informed Patient Consent form

Exclusion criteria

  • Prior renal transplant
  • History of active joint sepsis
  • Recent high dose of corticosteroids
  • Primary or secondary carcinoma in the last 5 years
  • Neurological disease
  • Psychosocial disease that would limit rehabilitation
  • Use of structural bone graft
  • Simultaneous participation in another hip study

Treatment and study plan

Acetabular cup

Device

Acetabular cup replacement

Other names: Pinnacle™ Cup

Primary outcomes

  1. Survivorship

    Time frame: 5 years

Secondary outcomes

  1. Harris Hip Score

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

  3. Short Form-36 (SF-36)

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

Important dates

Study start
2000
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2006
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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