- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450904
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
October 10, 2011 updated by: Mahidol University
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length
Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique.
It had the less postoperative pain and shorter recovery time compared to the conventional technique.
With using MIS technique, less cut of quadriceps tendon was the key.
It related to keep more quadriceps strength and improve functional performance after TKA.
However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength.
The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
The patients who diagnosed primary osteoarthritis of knee with
- varus or valgus deformity < 20 degrees
- preoperative range of motion > 90 degrees
- extension lag < 10 degrees
- Flexion contracture < 30 degrees
Exclusion Criteria:
- Bilateral simultaneous total knee arthroplasty
- Previous knee surgery
- Inadequate exposure during the surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
The length of Quadriceps incision was less than 2 cm.
|
MIS-TKA was performed with less than 2 cm Quadriceps incision length
|
Experimental: Group B
The length of Quadriceps incision was 2 to 4 cm.
|
MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
|
Experimental: Group C
The length of Quadriceps incision was more than 4 cm.
|
MIS-TKA was performed with more than 4 cm Quadriceps incision length
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The recovery time of Quadriceps strength
Time Frame: Upto 6 months
|
Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.
|
Upto 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keerati Charoencholvanich, MD, Mahidol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 10, 2011
First Posted (Estimate)
October 12, 2011
Study Record Updates
Last Update Posted (Estimate)
October 12, 2011
Last Update Submitted That Met QC Criteria
October 10, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si051/2554(EC2)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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