Is Isokinetic Testing an Indicator of Total Knee Arthroplasty

Is Isokinetic Knee Muscle Strength an Indicator of Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: isokinetic testing CSMI HUMAC NORM instrument

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Memorial Sisli Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgical knee group; This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups	Device: isokinetic testing CSMI HUMAC NORM instrument; 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.
Experimental: non surgical knee group; This study analyzed 58 knees of 29 unilateral TKA candidates, divided into the surgical and non-surgical knee groups	Device: isokinetic testing CSMI HUMAC NORM instrument; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	cross-sectional study, baseline
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	cross sectional study, baseline
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.	cross sectional study, baseline
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	cross sectional study, baseline

Collaborators and Investigators

• Sponsor: Bahçeşehir University
• Investigators: Principal Investigator: ilknur saral, Ass Prof, Bahcesehir University, Department of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: knee; arthroplasty; visual analog scale; diagnostic x-ray; muscle strength dynamometer
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 3 months after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No