Total Knee ArthroplastyNCT06297746
Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography
A study testing Subvastus approach and Medial Parapatellar approach in people with Total Knee Arthroplasty, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT INTRODUCTION Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Subvastus approach and Medial Parapatellar approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 1 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of primary osteoarthritis
Who cannot join
- Diagnosis of secondary osteoarthritis
- Uncontrolled diabetes
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Fatih, 34098
About this study
Official title: Comparison of Early Outcomes of Primary Total Knee Arthroplasties Performed Using Subvastus and Medial Parapatellar Approaches and Evaluation of Quadriceps Muscle Elastography
ABSTRACT
INTRODUCTION
Read more
Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.
MATERIALS AND METHODS
The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Subvastus approach, Medial Parapatellar approach
- Keywords
- Total Knee Arthroplasty, Subvastus Approach, Medial Parapatellar Approach, Shear Wave Elastography, Elastography, Young's Modulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subvastus approachProcedure or surgery
Subvastus approach
Medial Parapatellar approachProcedure or surgery
Medial Parapatellar approach
| Study group | Role | What they receive |
|---|---|---|
| Subvastus approach | Active comparator | Patients indicated for total knee arthroplasty. Receives: Procedure: Subvastus approach |
| Medial Parapatellar approach | Active comparator | Patients indicated for total knee arthroplasty. Receives: Procedure: Medial Parapatellar approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave values
Ultrasonic measurements
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start10 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mete Ozer, Istanbul University - Cerrahpasa
- Investigators
- Mehmet Fatih Güven, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297746
- Sponsor's protocol ID
- am7mi3VB
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All demographic data, clinical scores, and elastography measurement results will be shared.
Publications
Shinohara M, Sabra K, Gennisson JL, Fink M, Tanter M. Real-time visualization of muscle stiffness distribution with ultrasound shear wave imaging during muscle contraction. Muscle Nerve. 2010 Sep;42(3):438-41. doi: 10.1002/mus.21723.
PubMed 20665510Dutka J, Skowronek M, Sosin P, Skowronek P. Subvastus and medial parapatellar approaches in TKA: comparison of functional results. Orthopedics. 2011 Jun 14;34(6):148. doi: 10.3928/01477447-20110427-05.
PubMed 21667899Vaishya R, Vijay V, Demesugh DM, Agarwal AK. Surgical approaches for total knee arthroplasty. J Clin Orthop Trauma. 2016 Apr-Jun;7(2):71-9. doi: 10.1016/j.jcot.2015.11.003. Epub 2015 Dec 3.
PubMed 27182142Guven MF, Ozer M, Ozsahin MK, Deger GU, Adaletli I, Aykan Kargin O, Kaynak G, Botanlioglu H. Comparison of early outcomes of primary total knee arthroplasties performed using subvastus and medial parapatellar approaches and evaluation of quadriceps muscle elastography. Arch Orthop Trauma Surg. 2024 Nov;144(11):4839-4847. doi: 10.1007/s00402-024-05570-5. Epub 2024 Sep 23.
PubMed 39311941
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Outcomes of Primary Total Knee Arthroplasties Performed Using Subvastus and Medial Parapatellar Approaches and Evaluation of Quadriceps Muscle Elastography
- ClinicalTrials.gov ID
- NCT06297746
- Acronym / sponsor ID
- am7mi3VB
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Subvastus Approach, Medial Parapatellar Approach, Shear Wave Elastography, Elastography, Young's Modulus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Mar 2024 (actual)
- 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.
ABSTRACT
INTRODUCTION
Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.
MATERIALS AND METHODS
The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subvastus approach | Active comparator | Procedure: Subvastus approachPatients indicated for total knee arthroplasty. |
| Medial Parapatellar approach | Active comparator | Procedure: Medial Parapatellar approachPatients indicated for total knee arthroplasty. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of primary osteoarthritis
Key exclusion criteria (3 listed)
- Diagnosis of secondary osteoarthritis
- Uncontrolled diabetes
- Uncontrolled hypertension
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 |
|---|---|---|
| Subvastus approachSubvastus approach | Procedure or surgery | Subvastus approach |
| Medial Parapatellar approachMedial Parapatellar approach | Procedure or surgery | Medial Parapatellar approach |
Primary outcome
Shear wave values
Time frame: 3 month
Ultrasonic measurements
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 8 Mar 2024.
- Background: PubMed 20665510Shinohara M, Sabra K, Gennisson JL, Fink M, Tanter M. Real-time visualization of muscle stiffness distribution with ultrasound shear wave imaging during muscle contraction. Muscle Nerve. 2010 Sep;42(3):438-41. doi: 10.1002/mus.21723.
- Background: PubMed 21667899Dutka J, Skowronek M, Sosin P, Skowronek P. Subvastus and medial parapatellar approaches in TKA: comparison of functional results. Orthopedics. 2011 Jun 14;34(6):148. doi: 10.3928/01477447-20110427-05.
- Background: PubMed 27182142Vaishya R, Vijay V, Demesugh DM, Agarwal AK. Surgical approaches for total knee arthroplasty. J Clin Orthop Trauma. 2016 Apr-Jun;7(2):71-9. doi: 10.1016/j.jcot.2015.11.003. Epub 2015 Dec 3.
- Derived from this study: PubMed 39311941Guven MF, Ozer M, Ozsahin MK, Deger GU, Adaletli I, Aykan Kargin O, Kaynak G, Botanlioglu H. Comparison of early outcomes of primary total knee arthroplasties performed using subvastus and medial parapatellar approaches and evaluation of quadriceps muscle elastography. Arch Orthop Trauma Surg. 2024 Nov;144(11):4839-4847. doi: 10.1007/s00402-024-05570-5. Epub 2024 Sep 23.
- Individual participant dataSharing planned: Yes. All demographic data, clinical scores, and elastography measurement results will be shared.
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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.
Mehmet Fatih Güven principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subvastus approach and Medial Parapatellar approach in people with Total Knee Arthroplasty, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 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 8 Mar 2024. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Shear wave values (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297746, which also lists 4 linked publications.
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 8 Mar 2024.