- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912769
Knee Muscle Force Recovery After Minimally Invasive Surgery (MIS) Total Knee Replacement (TKR) (MISTKR)
June 2, 2009 updated by: Far Eastern Memorial Hospital
Outcome and Benefit After Total Knee Arthroplasty: Natural History of Muscle Power Recovery and Difference Between Different Surgical Approach
To compare muscle torque recovery between patients under subvastus approach and those under midvastus approach after total knee replacement
Study Overview
Status
Completed
Conditions
Detailed Description
Total knee Arthroplasty is a common operated surgery in each hospitals, and a lots of patients benefit from this surgery.
Traditionally the frequently used surgical approach is parapatellar approach.
However, recently the subvastus and midvastus approach has gained a world-wide population.
These two methods had less damage to the quadriceps tendon and theoretically should have better post-operative muscle power recovery, less lateral retinaculum release because of better patellar tracking.
The only differences between these two approaches are that the midvastus approach will split the vastus medialis muscle and denervation may occur.
In this study we will use HSS or KSS functional score and Cybex dynamometer to evaluate the functional recovery, and use Merchant's view radiography to evaluate the result of patellar tracking.
The follow-up period will not be limited and we will use mixed-model statistic's random effect to gain the natural history of muscle power recovery, which will become the base of other study.
We can also compare the difference of results between PS type and CR type and different surgical approach.
The natural history of the knee score will also be obtained.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taipei
-
Pan-Ciao, Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
-
-
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
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients after total knee replacement without severe systemic disorders
Description
Inclusion Criteria:
- Patients after subvastus approach or midvastus approach total knee replacement
Exclusion Criteria:
- patients with severe hypertension, heart disease or other problems which negatively influence the security of muscle test
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
Cohorts and Interventions
Group / Cohort |
|---|
|
subvastus approach/ midvastus approach
subvastus: vastus medialis oblique was not cut during operation midvastus: vastus medialis oblique was cut during operation
|
|
Cybex
Knee extension/ flexion isometric and isokinetic performance of all cases were tested using Cybex
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2003
Primary Completion (ACTUAL)
March 1, 2004
Study Completion (ACTUAL)
March 1, 2004
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (ESTIMATE)
June 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 3, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 97025
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.
Clinical Trials on Total Knee Replacement Approach
-
Central DuPage HospitalTerminatedTotal Knee Replacement | Replacement, Total Knee | Arthroplasty, Knee ReplacementUnited States
-
Concentra AI, incRecruitingTotal Hip Replacement | Total Knee ReplacementUnited States
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical AssociationCompletedTotal Hip Replacement | Total Knee ReplacementCanada
-
Mayo ClinicStryker OrthopaedicsCompletedArthroplasty, Replacement, Knee | Total Knee ReplacementUnited States
-
National University Hospital, SingaporeActive, not recruitingKnee Replacement, Total | Knee Replacement SurgerySingapore
-
Istanbul UniversityCompleted
-
Singapore General HospitalCompletedTotal Knee Arthroplasty | Total Knee ReplacementSingapore
-
Istanbul UniversityCompletedTotal Knee Arthroplasty | Total Knee ReplacementTurkey
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee Arthroplasty, Total | Knee Replacement, TotalUnited States
-
ElsanRecruitingKnee Replacement Arthroplasty | Knee Replacement, Total | Knee OsteoarthristisFrance