Does Implant Design Improve Postoperative Flexion?

DePuy Synthes

Status: Completed

Conditions: Non-inflammatory Arthritis

Treatments: Device: Total knee replacement using the PFC Sigma RP knee implant; Device: Total knee replacement using the PFC Sigma RPF knee implant.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380861

04092

Details and patient eligibility

About

This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.

Full description

The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.

Enrollment: 93 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-Inflammatory Arthritis
• Age = 40-70 years
• Male or female
• Suitable for devices in study
• Needing primary simultaneous bilateral knee replacements
• Willing to consent and authorize release of personal health information
• Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,

Exclusion criteria

• Existing conditions that would compromise participation
• Multiple joint involvement
• Pregnant/lactating women
• Inflammatory arthritis
• Fixed flexion contracture greater than 20 degrees
• Previous knee replacement of any type
• Needing device(s) not specified in protocol
• The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
• Those who have participated in an investigation in the last 3 months
• Those involved in personal injury litigation, medical-legal or workers compensation claims
• Failure to follow surgical technique details specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 2 patient groups

PFC Sigma RP-F

Active Comparator group

Description:

PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.

Treatment:

Device: Total knee replacement using the PFC Sigma RPF knee implant.

PFC Sigma RP

Active Comparator group

Description:

P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.

Treatment:

Device: Total knee replacement using the PFC Sigma RP knee implant