A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems

NCT ID: NCT00733499

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-01
• Study Completion Date: 2018-10-22

Brief Summary

The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.

Detailed Description

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LCS Complete Duofix

102 patients

Group Type: OTHER

LCS Complete Duofix

Intervention Type: DEVICE

Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces

LCS Complete Porocoat

104 patients

Group Type: ACTIVE_COMPARATOR

LCS Complete Porocoat

Intervention Type: DEVICE

Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces

Interventions

LCS Complete Duofix

Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces

Intervention Type: DEVICE

LCS Complete Porocoat

Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• 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.
• Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a cementless mobile bearing knee system (LCS Complete).
• Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with both the investigational devices, according to the indications specified in the package insert leaflet.

Exclusion Criteria

• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Subjects with a known history of poor compliance to medical treatment.
• Women 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 involved in Medical-Legal claims.
• Subjects who have participated in a clinical study with an investigational product in the last month.
• Subjects who are currently involved in any injury litigation claims.
• Revision of an existing knee implant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Musgrave Park Hospital

Belfast, , Ireland

Countries

Ireland

Other Identifiers

CT 05/28

Identifier Type: -

Identifier Source: org_study_id