N/A
Completed N=205
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
Source: ClinicalTrials.gov NCT00733499 ↗Enrolled (actual)
205
Serious AEs
61.5%
Results posted
Aug 2014
Primary outcomePrimary: Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months. — 2.51; 2.53 units on a scale — p=0.9478
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months. |
2.51; 2.53 | 0.9478 |
| SECONDARY 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. |
45.81; 45.40 | 0.5490 |
| SECONDARY 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. |
28.66; 29.45 | 0.5312 |
| SECONDARY 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. |
25.16; 26.10 | 0.3549 |
| SECONDARY 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. |
24.70; 27.17 | 0.0513 |
| SECONDARY 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. |
23.39; 25.68 | 0.0629 |
| SECONDARY 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. |
24.05; 27.25 | 0.0327 sig |
| SECONDARY 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. |
22.04; 25.49 | 0.0883 |
| SECONDARY 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. |
47.39; 47.54 | 0.6801 |
| SECONDARY 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. |
49.87; 48.21 | 0.4779 |
| SECONDARY 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. |
52.54; 51.99 | 0.8007 |
| SECONDARY 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. |
51.60; 49.83 | 0.3317 |
| SECONDARY 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. |
52.88; 52.81 | 0.8955 |
| SECONDARY 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. |
49.87; 47.38 | 0.2116 |
| SECONDARY 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. |
54.85; 53.49 | 0.4776 |
| SECONDARY Survivorship Analysis |
100; 98.9 | 0.2935 |
| SECONDARY 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. |
30.8; 24.81 | 0.0062 sig |
| SECONDARY 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. |
35.50; 34.64 | 0.6896 |
| SECONDARY 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. |
36.58; 33.31 | 0.1076 |
| SECONDARY 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. |
36.76; 36.56 | 0.9042 |
| SECONDARY 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. |
37.41; 37.49 | 0.9637 |
| SECONDARY 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. |
36.52; 32.93 | 0.0485 sig |
| SECONDARY 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. |
40.73; 40.78 | 0.9813 |
| SECONDARY Number of Participants With Tibial Radiolucency, 0-1mm |
13; 20; 14; 27; 14; 18 | — |
| SECONDARY Number of Participants With Tibial Radiolucency, 1mm-2mm |
13; 20; 14; 31; 21; 32 | — |
| SECONDARY Number of Participants With Tibial Radiolucency, Greater Than 2mm |
3; 6; 3; 5; 5; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00733499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.