NCT06096792

Brief Summary

Total knee arthroplasty (TKA) surgery is a common procedure performed to reduce pain, improve function, and enhance the quality of life in patients with end-stage knee osteoarthritis. As with other knee-related injuries and surgeries, TKA surgery can lead to inhibition of the quadriceps muscle, resulting in a decrease in the muscle's capacity to generate maximum voluntary force. This issue can negatively affect post-injury rehabilitation and function. The long-term persistent neuromuscular muscle inhibition in the quadriceps, one of the most important anti-gravity muscles in our body, leads to muscle atrophy and strength loss, which is more determinant in the development of functional limitations compared to joint range of motion and knee pain. There have been no studies found that assess the quadriceps muscle inhibition occurring during the hospitalization of patients undergoing total knee arthroplasty surgery and examine its impact on post-discharge functional status. The aim of this study is to evaluate the severity of arthrogenic inhibition in the quadriceps muscle of patients following total knee arthroplasty surgery, which is widely practiced in our country and considered the gold standard for the treatment of end-stage knee osteoarthritis. Additionally, the study aims to investigate its impact on post-discharge functional recovery. The data obtained from this study will provide guidance in monitoring patients' early functional recovery post-surgery and in better planning post-surgical rehabilitation. The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.

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 all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

October 18, 2023

Last Update Submit

March 12, 2026

Conditions

Keywords

knee arthroplastyKnee osteoarthritismuscle inhibition

Outcome Measures

Primary Outcomes (1)

  • muscle inhibition

    Quadriceps maximum isometric muscle contraction will be evaluated by measuring the pneumatic pressure change with a pneumatic dynamometer.

    postoperative day-1; postoperative day-2; postoperative day-3; postoperative 2th week and postoperative 6th week

Secondary Outcomes (1)

  • Functional recovery

    postoperative 2th week and postoperative 6th week

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent total knee arthroplasty at Hacettepe University faculty of medicine

You may qualify if:

  • Age between 50 and 75 years.
  • Have undergone unilateral total knee arthroplasty surgery due to osteoarthritis.
  • Hemodynamically stable post-surgery.
  • Willing to participate in the study.

You may not qualify if:

  • Having any neurological or oncological issues.
  • Having undergone revision surgery.
  • Having a history of cardiovascular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sibel Bozgeyik Bağdatlı, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

October 10, 2024

Primary Completion

March 20, 2025

Study Completion

September 11, 2025

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations