A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee

NCT00733486 | Terminated Phase 4

• 1 other identifier: CT 02/41
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years. The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.

Conditions

Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);

Outcome Measures

Primary Outcomes (1)

• A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.

  2 years

Secondary Outcomes (21)

• Changes from baseline to 3 months post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score.

  Pre-op to 3 months

• Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score

  Pre-op to 1 year

• Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score

  Pre-op to 3 years

• Incidence of anterior knee pain and patellar function using the Patellar Score

  3 months post-operatively

• Incidence of anterior knee pain and patellar function using the Patellar Score

  1 year post-operatively

Study Arms (1)

L.C.S. APG Knee Anterior Posterior Glide knee

OTHER

Orthopaedic implant for primary knee replacement

Device: L.C.S. APG Knee Anterior Posterior Glide knee

Interventions

L.C.S. APG Knee Anterior Posterior Glide knee DEVICE

Orthopaedic implant for primary knee replacement

L.C.S. APG Knee Anterior Posterior Glide knee

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, aged between 45 and 85 years inclusive.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
• Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
• Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, according to the indications specified in the package insert leaflet.

You may not qualify if:

• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Revision of an existing knee implant (including unicompartmental implants).
• Female subjects who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
• Subjects who are currently involved in any personal injury litigation claims.
• Subjects involved in personal Medical-Legal claims.
• Subjects with a known history of poor compliance to medical treatment.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (3)

Dong-A University medical centre

Pusan, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Severance Hospital, Yongsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: August 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

KR (3)