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

NCT00733499 | Completed Results

• 1 other identifier: CT 05/28
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Arthroplasty, replacement, Knee, LCS Duofix, Porocoat

Outcome Measures

Primary Outcomes (1)

• Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.

  The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint

  12 Months Post Surgery

Secondary Outcomes (26)

• Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.

  Pre-op

• Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.

  3 months

• Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.

  6 months

• Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.

  12 months

• Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.

  24 months

Study Arms (2)

LCS Complete Duofix

OTHER

102 patients

Device: LCS Complete Duofix

LCS Complete Porocoat

ACTIVE COMPARATOR

104 patients

Device: LCS Complete Porocoat

Interventions

LCS Complete Duofix DEVICE

Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces

LCS Complete Duofix

LCS Complete Porocoat DEVICE

Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces

LCS Complete Porocoat

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Musgrave Park Hospital

Belfast, BT9 7JB, Ireland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

This is a single surgeon/site study.

Results Point of Contact

• Title: Tamiko Magee-Rodgers, PhD
• Organization: DePuy Ortho Joint US

TMageeRo@its.jnj.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: September 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 22, 2018
• Last Updated: January 14, 2020
• Results First Posted: August 4, 2014

Record last verified: 2019-12

Locations

IE (1)