Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733915
• Other study ID #: CT 01/13
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: August 1, 2016
• Start date: March 2002
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.

Description:

The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 2014
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 mobile bearing knee system (LCS Complete).

• Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, 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 effect 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
L.C.S. Complete mobile-bearing total knee system

Locations

Country	Name	City	State
Ireland	Musgrave Park Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment		10 years	No
Secondary	To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.		Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years	Yes