NCT00289094

Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Completed NA Results posted Last updated 13 September 2022

What this trial tests

NA trial testing Total Knee Replacement in Osteoarthritis in 99 participants. Completed in 26 December 2007.

Timeline

1 March 2001

Primary endpoint
26 December 2007

26 December 2007

Quick facts

Lead sponsor	DePuy Orthopaedics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	99
Start date	1 March 2001
Primary completion	26 December 2007
Estimated completion	26 December 2007
Sites	2 locations across United States

Drugs / interventions tested

• Total Knee Replacement
• Total knee replacement

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Post-traumatic Arthritis — all drugs for Post-traumatic Arthritis →
• Juvenile Rheumatoid Arthritis — all drugs for Juvenile Rheumatoid Arthritis →

Sponsor

DePuy Orthopaedics — full company profile →

Who can join

Adults 18 to 75, any sex, with Osteoarthritis or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knee Society Scores Primary · Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.

Pre-operative

Group	Value	95% CI
Rotating Platform	40.8	± 19.8
Fixed Bearing	43.4	± 23.0

6 months

Group	Value	95% CI
Rotating Platform	84.3	± 14.7
Fixed Bearing	77.8	± 14.9

12 months

Group	Value	95% CI
Rotating Platform	86.4	± 13.0
Fixed Bearing	86.4	± 10.0

24 months

Group	Value	95% CI
Rotating Platform	89.7	± 9.2
Fixed Bearing	88.1	± 8.8

36 months

Group	Value	95% CI
Rotating Platform	92.3	± 8.2
Fixed Bearing	87.1	± 10.4

48 months

Group	Value	95% CI
Rotating Platform	94.3	± 5.6
Fixed Bearing	86.0	± 14.7

60 months

Group	Value	95% CI
Rotating Platform	95.0	± 4.6
Fixed Bearing	95.5	± 3.5

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rotating Platform

Serious: 3/50 (6%)

Deaths: —

Fixed Bearing

Serious: 1/49 (2%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Rotating Platform	Fixed Bearing
Cardiacvascular arrhythmia	Cardiac disorders	—	—
Death	General disorders	—	—
Femoral Fracture	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Cardiacvascular arrhythmia, Death, Femoral Fracture.

Data from ClinicalTrials.gov NCT00289094 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mobile bearing vs fixed bearing prostheses for posterior cruciate retaining total knee arthroplasty for postoperative functional status in patients with osteoarthritis and rheumatoid arthritis.
   Hofstede SN, Hofstede SN, Nouta KA, Jacobs W, et al · · 2015 · cited 28× · PMID 25650566 · DOI 10.1002/14651858.cd003130.pub3