Is Isokinetic Testing an Indicator of Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Is Isokinetic Knee Muscle Strength an Indicator of Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668546
• Other study ID #: 395
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: December 2022
• Source: Bahçesehir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Turkey	Memorial Sisli Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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