NCT06297746

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 1, 2024

Last Update Submit

March 6, 2024

Conditions

Total Knee Arthroplasty

Keywords

Total Knee ArthroplastySubvastus ApproachMedial Parapatellar ApproachShear Wave ElastographyElastographyYoung's Modulus

Outcome Measures

Primary Outcomes (1)

  • Shear wave values

    Ultrasonic measurements

    3 month

Study Arms (2)

Subvastus approach

ACTIVE COMPARATOR

Patients indicated for total knee arthroplasty.

Procedure: Subvastus approach

Medial Parapatellar approach

ACTIVE COMPARATOR

Patients indicated for total knee arthroplasty.

Procedure: Medial Parapatellar approach

Interventions

Subvastus approachPROCEDURE

Subvastus approach

Subvastus approach
Medial Parapatellar approachPROCEDURE

Medial Parapatellar approach

Medial Parapatellar approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Diagnosis of primary osteoarthritis

You may not qualify if:

  • Diagnosis of secondary osteoarthritis
  • Uncontrolled diabetes
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 20665510BACKGROUND

  • 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.

    PMID: 21667899BACKGROUND

  • 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.

    PMID: 27182142BACKGROUND

  • Guven 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.

    PMID: 39311941DERIVED

Study Officials

  • Mehmet Fatih Güven

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

July 10, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

All demographic data, clinical scores, and elastography measurement results will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU(1)