Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

DePuy Orthopaedics

ClinicalTrials.gov Identifier:

NCT00289094

First received: February 7, 2006

Last updated: September 30, 2011

Last verified: September 2011

History of Changes

Results First Received: September 29, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Conditions:	Osteoarthritis Rheumatoid Arthritis Avascular Necrosis of Bone
Interventions:	Device: Total Knee Arthroplasty Device: Total knee replacement

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Rotating Platform	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.
Fixed Bearing	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraopertively locked into position on the metal tibial base.

Participant Flow: Overall Study

	Rotating Platform	Fixed Bearing
STARTED	50	49
COMPLETED	3	2
NOT COMPLETED	47	47

Baseline Characteristics

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Reporting Groups

	Description
Rotating Platform	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.
Fixed Bearing	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraopertively locked into position on the metal tibial base.
Total	Total of all reporting groups

Baseline Measures

	Rotating Platform	Fixed Bearing	Total
Number of Participants [units: participants]	50	49	99
Age [units: years] Mean ± Standard Deviation	63.7 ± 6.2	66.9 ± 5.1	65.3 ± 5.9
Gender [units: participants]
Female	31	26	57
Male	19	23	42
Region of Enrollment [units: participants]
United States	50	49	99

Outcome Measures

1. Primary:

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

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2. Secondary:

Complications/Revisions [ Time Frame: On-going to end of study. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

3. Secondary:

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

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

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

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Tammy O'Dell, EMT, CCRA
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7104
e-mail: TOdell2@its.jnj.com

No publications provided

Responsible Party:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00289094 History of Changes
Other Study ID Numbers:	SRP-2
Study First Received:	February 7, 2006
Results First Received:	September 29, 2010
Last Updated:	September 30, 2011
Health Authority:	United States: Food and Drug Administration

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