Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

• Sponsor: DePuy Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00289094
• Collaborator: (none)
• Enrollment: 99
• Locations: 2
• Arms: 2
• Duration (Months): 102
• Patients Per Site: 49.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Juvenile Rheumatoid Arthritis; Avascular Necrosis of Bone	Device: Total Knee Replacement; Device: Total knee replacement	N/A

Detailed Description

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
• Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System	Device: Total Knee Replacement; Rotating Platform (RP) Cruciate Retaining Knee System; Other Names: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
Active Comparator: 2 P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System	Device: Total knee replacement; Fixed Cruciate Retaining Knee System; Other Names: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System

Outcome Measures

Primary Outcome Measures

1. Knee Society Scores [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.

Secondary Outcome Measures

1. Complications/Revisions [On-going to end of study.]

2. Medical Imaging [Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

3. SF-12 Patient Outcomes [Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Osteoarthritis

• Rheumatoid Arthritis

• Other inflammatory arthritis

• Avascular necrosis of bone

Exclusion Criteria:

• Prior ipsilateral TKA

• Metabolic disorders

• Joint replacement due to autoimmune disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Billings	Montana	United States	59101
2		Vancouver	Washington	United States	98664

Sponsors and Collaborators

• DePuy Orthopaedics

Investigators

• Study Director: Tammy L O'Dell, EMT, CCRA, CCRC, DePuy Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT00289094
• Other Study ID Numbers: SRP-2
• First Posted: Feb 9, 2006
• Last Update Posted: Aug 14, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Osteonecrosis; Necrosis

Study Results

Participant Flow

Recruitment Details	Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.
Pre-assignment Detail	Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.

Arm/Group Title	Rotating Platform	Fixed Bearing
Arm/Group Description	P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
Period Title: Overall Study
STARTED	50	49
COMPLETED	3	2
NOT COMPLETED	47	47

Baseline Characteristics

Arm/Group Title	Rotating Platform	Fixed Bearing	Total
Arm/Group Description	P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.	Total of all reporting groups
Overall Participants	50	49	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (6.2)	66.9 (5.1)	65.3 (5.9)
Sex: Female, Male (Count of Participants)
Female	31 62%	26 53.1%	57 57.6%
Male	19 38%	23 46.9%	42 42.4%
Region of Enrollment (participants) [Number]
United States	50 100%	49 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	Knee Society Scores
Description	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.
Time Frame	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rotating Platform	Fixed Bearing
Arm/Group Description	P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
Measure Participants	50	49
Pre-operative	40.8 (19.8)	43.4 (23.0)
6 months	84.3 (14.7)	77.8 (14.9)
12 months	86.4 (13.0)	86.4 (10.0)
24 months	89.7 (9.2)	88.1 (8.8)
36 months	92.3 (8.2)	87.1 (10.4)
48 months	94.3 (5.6)	86.0 (14.7)
60 months	95.0 (4.6)	95.5 (3.5)

2. Secondary Outcome

Title	Complications/Revisions
Time Frame	On-going to end of study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Medical Imaging
Time Frame	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	SF-12 Patient Outcomes
Time Frame	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Rotating Platform		Fixed Bearing
Arm/Group Description	P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.		P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
All Cause Mortality
	Rotating Platform		Fixed Bearing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rotating Platform		Fixed Bearing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/50 (6%)		1/49 (2%)
Cardiac disorders
Cardiacvascular arrhythmia	2/50 (4%)	2	0/49 (0%)	0
General disorders
Death	1/50 (2%)	1	0/49 (0%)	0
Musculoskeletal and connective tissue disorders
Femoral Fracture	0/50 (0%)	0	1/49 (2%)	1
Other (Not Including Serious) Adverse Events
	Rotating Platform		Fixed Bearing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.