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Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02683460
Recruitment Status : Unknown
Verified February 2016 by Yong In, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

Brief Summary:

This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.

This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Patella Resurfacing Procedure: Patella resurfacing Procedure: Patella retention Not Applicable

Detailed Description:

The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.

Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: patella resurfacing group
Procedure: Patellar component Resurfacing with onlay technique
Procedure: Patella resurfacing
Active Comparator: patella retention
Procedure: patellar retention Trimming of osteophytes when appropriate
Procedure: Patella retention



Primary Outcome Measures :
  1. WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale [ Time Frame: Change from preoperative score to postoperative 2 years ]
  2. Knee Society score [ Time Frame: Change from preoperative score to postoperative 2 years ]

Secondary Outcome Measures :
  1. Feller's score [ Time Frame: Change from preoperative score to postoperative 2 years ]
  2. Patients satisfaction using Visual Analog Score for pain [ Time Frame: Change from preoperative score to postoperative 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients for total knee arthroplasty
  • Having medicare insurance

Exclusion Criteria:

  • Patients who are not able to cooperate
  • Serious deformity (not suitable for a standard TKA prosthesis)
  • Patellar thickness less than 18 mm
  • Prior operation involving the extensor mechanism
  • Rheumatoid arthritis
  • Severe medical disability limiting the ability to walk
  • Revision surgery
  • Knees with predominantly patellofemoral arthrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683460


Contacts
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Contact: Yong In, MD, PhD 8290445228 iy1000@catholic.ac.kr
Contact: Mansoo Kim, MD 8272333875 kms3779@naver.com

Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Yong In, MD, PhD the Catholic Univerisity of Korea Seoul St Mary's hospital
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Responsible Party: Yong In, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02683460    
Other Study ID Numbers: Patella resurfacing
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases