Total Knee Replacement ApproachMISTKRNCT00912769
Knee Muscle Force Recovery After Minimally Invasive Surgery (MIS) Total Knee Replacement (TKR)
An observational study of Total Knee Replacement Approach and Muscle Torque, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare muscle torque recovery between patients under subvastus approach and those under midvastus approach after total knee replacement Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Replacement Approach, Muscle Torque
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2003to Mar 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after total knee replacement without severe systemic disorders
Who may be able to join
- Patients after subvastus approach or midvastus approach total knee replacement
Who cannot join
- patients with severe hypertension, heart disease or other problems which negatively influence the security of muscle test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Total Knee Replacement Approach, Muscle Torque
- Keywords
- Total knee replacement, Subvastus, Midvastus, Isokinetic, Quadriceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startOct 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement ApproachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912769
- Sponsor's protocol ID
- 97025
- Other IDs
- 97025
- Acronym
- MISTKR
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Benefit After Total Knee Arthroplasty: Natural History of Muscle Power Recovery and Difference Between Different Surgical Approach
- ClinicalTrials.gov ID
- NCT00912769
- Acronym / sponsor ID
- MISTKR / 97025
- Conditions
- Total Knee Replacement Approach, Muscle Torque
- Keywords
- Total knee replacement, Subvastus, Midvastus, Isokinetic, Quadriceps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare muscle torque recovery between patients under subvastus approach and those under midvastus approach after total knee replacement
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after total knee replacement without severe systemic disorders
Key inclusion criteria (1 listed)
- Patients after subvastus approach or midvastus approach total knee replacement
Key exclusion criteria (1 listed)
- patients with severe hypertension, heart disease or other problems which negatively influence the security of muscle test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement Approach and Muscle Torque, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.