Clinical trial NCT00380861: Does Implant Design Improve Postoperative Flexion?
Official title: Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Arthritis
Keywords: Total Knee Replacement
Flexion
Range of Motion
Activities of Daily Living
Implant design
Subject Satisfaction
Non-inflammatory arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 93
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Passive Flexion at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee
timeFrame: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
measure: Patient Specific Anthropometrics
timeFrame: Collected at pre-op
measure: American Knee Society (AKS) Score
timeFrame: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
measure: KOOS Pain Sub-score
timeFrame: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
measure: Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
timeFrame: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
measure: Patellar Crepitus Defined as No Crepitus, FINE or COARSE
timeFrame: Collected at Pre-operative, 6 weeks and 6 and 12 months
measure: Subject Satisfaction
timeFrame: Collected pre-and post-op, reported at 12-months
measure: Single Leg Active Flexion (SLAF)
timeFrame: Pre-op, 6- and 12-months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Doug Dennis
state: Colorado
city: Jacksonville
country: United States
facility: Heekin Orthopaedics
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
state: Iowa
city: Lakewood
country: United States
facility: Lakewood Orthopaedic Surgeons
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Tammy O'Dell, EMT, CCRA, CCRC
role: STUDY_DIRECTOR
References:
citation: Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available.