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Is Isokinetic Testing an Indicator of Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
isokinetic testing CSMI HUMAC NORM instrument
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Knee Osteoarthritis focused on measuring arthroplasty, diagnostic x-ray, knee, muscle strength dynamometer, visual analog scale

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of advanced (Kellgren-Lawrence stage 3 or 4) bilateral knee osteoarthritis (OA). Unilateral total knee replacement surgery recommended by orthopedics according to pain status Exclusion Criteria: Neurological diseases that could affect knee muscle strength Rheumatological diseases Diagnosis of osteoarthritis below 3 according to Kellgren-Lawrence classification

Sites / Locations

  • Memorial Sisli Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

surgical knee group

non surgical knee group

Arm Description

This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups

This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups

Outcomes

Primary Outcome Measures

Knee flexion and extension muscle strengths assessed by isokinetic dynamometer
In the isokinetic evaluation, both 60 PT_E (Peak Torque _Extension) and 60 PT_F (Peak Torque_Flexion) were evaluated.The tests were repeated five times at each velocity, and the highest PTs were selected for statistical analysis. The participants performed repeated trials before sets, while a 20-second rest was provided between sets.
Osteoartritis gradings assessed by Kellgren-Lawrence grading system
Kellgren-Lawrence grading system was used. Each radiograph was assigned a grade from 0 to 4, which correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA
Pain assessed by Visual analog scale
The visual analog scale (VAS) pain score of each individual was also recordedThe Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Investigators asked the patient to rate their current level of pain by placing a mark on the line.
Quadriceps angle
Q angle of knees were recorded. It is defined as the angle formed between the quadriceps muscles and the patella tendon.The Q angle measured in standing. Normal Q angle score for females is between 13-18° and in males is between 12-15°, with values greater than and lesser these are considered abnormal

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
December 19, 2022
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05668546
Brief Title
Is Isokinetic Testing an Indicator of Total Knee Arthroplasty
Official Title
Is Isokinetic Knee Muscle Strength an Indicator of Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, investigators analyzed whether the isokinetic knee muscle strength of patients undergoing unilateral total knee arthroplasty (TKA) is a predictor for surgery. Patients and Methods: In total, 29 unilateral TKA candidates (58 knees; mean age = 66.69 ± 7.42 years; mean symptom duration = 10 ± 5.40 years) were enrolled. The knees of patients with bilateral advanced knee osteoarthritis (stage 3 or 4), according to the Kellgren-Lawrence (K-L scale), that were scheduled for unilateral TKA were divided into surgical and non-surgical groups. An isokinetic testing system was used to assess knee flexor and extensor muscle strength (peak torque) at angular velocities of 60°/s and 180°/s (five cycles per velocity). The radiological (X-ray-based K-L scale and magnetic resonance imaging (MRI)-based quadriceps angle) and clinical findings (isokinetic test and visual analog scale pain scores) in both groups were compared. The isokinetic test results correlated with the radiological findings of the surgery group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
arthroplasty, diagnostic x-ray, knee, muscle strength dynamometer, visual analog scale

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
After the surgical decision was made, the patients were referred to the physiatrist by the orthopedist without informing which knee would be operated on. The physiatrist and the patient did not know which knee would be operated, so the tests were performed blindly.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgical knee group
Arm Type
Experimental
Arm Description
This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups
Arm Title
non surgical knee group
Arm Type
Experimental
Arm Description
This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups
Intervention Type
Device
Intervention Name(s)
isokinetic testing CSMI HUMAC NORM instrument
Intervention Description
The strength (PT) of the bilateral knee flexors and extensors were tested with isokinetic test. Tests were performed under the guidance of a rehabilitation medicine specialist, and the system was calibrated prior to their commencement. The patients were seated in upright position and were fixed with pelvic and thigh belts. Concentric extension (PT_E) and concentric flexion (PT_F) were measured between the 0° and 90° knee ranges at angular velocities of 60°/s and 180°/s (60 PT_E, 60 PT_F, 180 PT_E, and 180 PT_F, respectively) The tests were repeated five times at each velocity, and the highest PTs were selected for statistical analysis. The participants performed repeated trials before sets, while a 20-second rest was provided between sets.
Primary Outcome Measure Information:
Title
Knee flexion and extension muscle strengths assessed by isokinetic dynamometer
Description
In the isokinetic evaluation, both 60 PT_E (Peak Torque _Extension) and 60 PT_F (Peak Torque_Flexion) were evaluated.The tests were repeated five times at each velocity, and the highest PTs were selected for statistical analysis. The participants performed repeated trials before sets, while a 20-second rest was provided between sets.
Time Frame
cross-sectional study, baseline
Title
Osteoartritis gradings assessed by Kellgren-Lawrence grading system
Description
Kellgren-Lawrence grading system was used. Each radiograph was assigned a grade from 0 to 4, which correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA
Time Frame
cross sectional study, baseline
Title
Pain assessed by Visual analog scale
Description
The visual analog scale (VAS) pain score of each individual was also recordedThe Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Investigators asked the patient to rate their current level of pain by placing a mark on the line.
Time Frame
cross sectional study, baseline
Title
Quadriceps angle
Description
Q angle of knees were recorded. It is defined as the angle formed between the quadriceps muscles and the patella tendon.The Q angle measured in standing. Normal Q angle score for females is between 13-18° and in males is between 12-15°, with values greater than and lesser these are considered abnormal
Time Frame
cross sectional study, baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of advanced (Kellgren-Lawrence stage 3 or 4) bilateral knee osteoarthritis (OA). Unilateral total knee replacement surgery recommended by orthopedics according to pain status Exclusion Criteria: Neurological diseases that could affect knee muscle strength Rheumatological diseases Diagnosis of osteoarthritis below 3 according to Kellgren-Lawrence classification
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ilknur saral, Ass Prof
Organizational Affiliation
Bahcesehir University, Department of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sisli Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 3 months after publication

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Is Isokinetic Testing an Indicator of Total Knee Arthroplasty

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