Osteoarthritis of KneeNCT01450904
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
A study testing Quadriceps incision < 2 cm, Quadriceps incision 2-4 cm and Quadriceps incision > 4 cm in people with Osteoarthritis of Knee, run by Mahidol University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Quadriceps incision < 2 cm, Quadriceps incision 2-4 cm and Quadriceps incision > 4 cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bilateral simultaneous total knee arthroplasty
- Previous knee surgery
- Inadequate exposure during the surgery
About this study
Official title: 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.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Quadriceps incision < 2 cm, Quadriceps incision 2-4 cm, Quadriceps incision > 4 cm
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps incision < 2 cmProcedure or surgery
MIS-TKA was performed with less than 2 cm Quadriceps incision length
Quadriceps incision 2-4 cmProcedure or surgery
MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
Quadriceps incision > 4 cmProcedure or surgery
MIS-TKA was performed with more than 4 cm Quadriceps incision length
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The length of Quadriceps incision was less than 2 cm. Receives: Procedure: Quadriceps incision < 2 cm |
| Group B | Experimental | The length of Quadriceps incision was 2 to 4 cm. Receives: Procedure: Quadriceps incision 2-4 cm |
| Group C | Experimental | The length of Quadriceps incision was more than 4 cm. Receives: Procedure: Quadriceps incision > 4 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recovery time of Quadriceps strength
Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.
Measured: Upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keerati Charoencholvanich, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450904
- Sponsor's protocol ID
- Si051/2554(EC2)
- Status last verified
- Oct 2011
- First submitted
- 6 Oct 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length
- ClinicalTrials.gov ID
- NCT01450904
- Acronym / sponsor ID
- Si051/2554(EC2)
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Oct 2011 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Quadriceps incision < 2 cmThe length of Quadriceps incision was less than 2 cm. |
| Group B | Experimental | Procedure: Quadriceps incision 2-4 cmThe length of Quadriceps incision was 2 to 4 cm. |
| Group C | Experimental | Procedure: Quadriceps incision > 4 cmThe length of Quadriceps incision was more than 4 cm. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients who diagnosed primary osteoarthritis of knee with
Key exclusion criteria (3 listed)
- Bilateral simultaneous total knee arthroplasty
- Previous knee surgery
- Inadequate exposure during the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps incision < 2 cmMIS-TKA was performed with less than 2 cm Quadriceps incision length | Procedure or surgery | Group A |
| Quadriceps incision 2-4 cmMIS-TKA was performed with 2 to 4 cm Quadriceps incision length | Procedure or surgery | Group B |
| Quadriceps incision > 4 cmMIS-TKA was performed with more than 4 cm Quadriceps incision length | Procedure or surgery | Group C |
Primary outcome
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.
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 12 Oct 2011.
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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.
Keerati Charoencholvanich, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps incision < 2 cm, Quadriceps incision 2-4 cm and Quadriceps incision > 4 cm in people with Osteoarthritis of Knee, run by Mahidol University.
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 5 inclusion and 3 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
The recovery time of Quadriceps strength (time frame: Upto 6 months). It is what the study was designed to measure, not a finding.
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 12 Oct 2011.