Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01312532
First received: March 9, 2011
Last updated: NA
Last verified: June 2004
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 9, 2011 | ||||
| Last Updated Date | March 9, 2011 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Knee Society Scoring [ Time Frame: five years after surgery ] [ Designated as safety issue: Yes ] was used for evaluating the function of the knee and high scores indicated better knee function |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Pain [ Time Frame: five years after surgery ] [ Designated as safety issue: Yes ] Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain). |
||||
| 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 | Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial | ||||
| Official Title ICMJE | Study of Prosthesis in Total Knee Arthroplasty | ||||
| Brief Summary | The purpose of this study is to determine which prosthesis is better in total knee arthroplasty |
||||
| Detailed Description | Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | November 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01312532 | ||||
| Other Study ID Numbers ICMJE | ASD-1213-17 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences | ||||
| Study Sponsor ICMJE | Isfahan University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Isfahan University of Medical Sciences | ||||
| Verification Date | June 2004 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||