N/A
Completed N=22
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Knee Prosthesis · Knee Arthroplasty
Source: ClinicalTrials.gov NCT01290640 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. — -3.51; -2.52; -1.68; -1.40 mm
Summary
The objectives of this study are four-fold:
1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient.
2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise).
3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types.
4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. |
-3.51; -2.52; -1.68; -1.40; -10.31; 2.89 | — |
| PRIMARY In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. |
8.35; 1.99; 12.22; -2.42; 6.66; .13 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be at least three months post-operative.
- Potential subjects will have a body weight of less than 250 lbs.
- Candidates must have had a HSS score >90 post-operatively.
- Patients must have passive flexion of at least 100.
- All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis.
- Must be willing to sign both Informed Consent and HIPAA forms.
Exclusion Criteria
- Pregnant females.
- Patients that do not meet study requirements.
Data sourced from ClinicalTrials.gov (NCT01290640). 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. Informational only — not medical advice.