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Completed

NCT Number: NCT00289107

Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Juvenile Rheumatoid Arthritis Musculoskeletal Diseases Necrosis Osteonecrosis Other Inflammatory Arthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greensboro, North Carolina, United States

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About this study

The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoarthritis
  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Avascular necrosis (AVN) of bone
  • Post-Traumatic Arthritis
  • Juvenile Rheumatoid Arthritis

Exclusion criteria

  • History of recent/active joint sepsis.
  • Charcot neuropathy.
  • Psycho-social disorders that would limit rehabilitation.
  • Greater than 75 years of age at the time of surgery.
  • Prior ipsilateral knee arthroplasty.
  • Metabolic disorders of calcified tissues, such as Paget's disease.
  • Severe diabetes mellitus.
  • Joint replacement due to autoimmune disorders.
  • Skeletal immaturity

Treatment and study plan

Total knee arthroplasty

Device

Rotating Platform (RP) Cruciate Substituting Knee System

Other names: P.F.C.® Sigma™ RP Cruciate Substituting Knee System

Total knee replacement

Device

Fixed Cruciate Substituting Knee System

Other names: P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Primary outcomes

  1. Knee Society Score

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

    The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.

Secondary outcomes

  1. Complications

    Time frame: On-going to end of study

  2. Revisions

    Time frame: On-going to end of study

  3. Medical Imaging

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

  4. SF-12 Patient Outcomes

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Feb 9, 2006
Registry last updated
May 3, 2023

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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