NCT00733499CompletedNot Applicable
A Prospective, Randomised, Single Blinded Study Comparing the Pain, Biological Fixation and Outcomes of Patients With LCS Complete Duofix or LCS Porocoat Knee Systems
DePuy International2 sites in 1 country206 target enrollmentStarted: September 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Time Frame: 12 Months Post Surgery
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
Secondary Outcomes
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.(6 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.(60 months)
- Survivorship Analysis(9.99 years)
- 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 12 Months.(12 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.(120 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.(24 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.(60 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 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 24 Months.(24 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.(pre-op)
- Number of Participants With Tibial Radiolucency, Greater Than 2mm(3 months to 120 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 60 Months.(60 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 120 Months.(120 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.(3 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.(12 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.(12 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.(24 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Preop.(preop)
- Number of Participants With Tibial Radiolucency, 1mm-2mm(3 months to 120 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.(3 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.(6 months)
- Number of Participants With Tibial Radiolucency, 0-1mm(3 months to 120 months)
- Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.(120 months)
Investigators
Study Sites (2)
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