The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty
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| First Received Date ICMJE | January 22, 2013 | ||||||||
| Last Updated Date | January 25, 2013 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in quadriceps strength [ Time Frame: preop, 6 weeks, 3 months, 1 year postop ] [ Designated as safety issue: No ] Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01777009 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty | ||||||||
| Official Title ICMJE | A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty. | ||||||||
| Brief Summary | Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference. |
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| Detailed Description | Background: Patellar mobilization during total knee arthroplasty (TKA) has been debated, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomized, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty. Methods: After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomized to one of two patella exposure techniques: lateral retraction or eversion. Collaborating investigators and patients were blinded to randomization. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Primary Total Knee Replacement Surgery
Patients randomized to the eversion group had patellas everted during the flexion portions of the surgery. Patients randomized to the retraction group had patellas everted only for the patellar resurfacing portions of the surgery. Both groups were mobilized with anterior tibial translation. All other aspects of surgery including postoperative care, anticoagulation, pain control, and physical therapy were done as per standard arthroplasty protocols at our institution. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | April 2012 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01777009 | ||||||||
| Other Study ID Numbers ICMJE | Patellar Mobilization | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | North Shore Long Island Jewish Health System | ||||||||
| Study Sponsor ICMJE | North Shore Long Island Jewish Health System | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | North Shore Long Island Jewish Health System | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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