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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06297746
Other study ID # am7mi3VB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date December 1, 2023

Study information

Verified date March 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Eligibility Criteria: Inclusion Criteria: - Diagnosis of primary osteoarthritis Exclusion Criteria: - Diagnosis of secondary osteoarthritis - Uncontrolled diabetes - Uncontrolled hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Subvastus approach
Subvastus approach
Medial Parapatellar approach
Medial Parapatellar approach

Locations

Country Name City State
Turkey Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Dutka 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. — View Citation

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. — View Citation

Vaishya 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Shear wave values Ultrasonic measurements 3 month
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