N/A
N=184
Does Implant Design Improve Postoperative Flexion?
Non-inflammatory Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00380861 ↗Enrolled (actual)
184
Serious AEs
2.7%
Results posted
Apr 2011
Primary outcome: Primary: Knee Society Passive Flexion at 6 Months — 124.2; 124.0 Degrees of passive flexion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total knee replacement using the PFC Sigma RPF knee implant. (Device); Total knee replacement using the PFC Sigma RP knee implant (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- DePuy Orthopaedics
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Passive Flexion at 6 Months |
124.2; 124.0 | — |
| SECONDARY 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 |
111.6; 118.9; 120.2; 111.4; 120.9; 124.7 | — |
| SECONDARY Patient Specific Anthropometrics |
50.2; 24.8; 3.23 | — |
| SECONDARY American Knee Society (AKS) Score |
85.6; 87.0 | — |
| SECONDARY KOOS Pain Sub-score |
45.7; 84.0; 89.5; 45.3; 83.1; 90.0 | — |
| SECONDARY Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs |
49.0; 85.4; 90.4; 47.9; 85.6; 90.1 | — |
| SECONDARY Patellar Crepitus Defined as No Crepitus, FINE or COARSE |
15; 13; 44; 41; 52; 52 | — |
| SECONDARY Subject Satisfaction |
84 | — |
| SECONDARY Single Leg Active Flexion (SLAF) |
124.6; 126.0; 126.6; 120.9; 125.2; 127.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00380861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.