The Effect of the Physiotherapy Program Added to the ERAS Protocol in Patients With Total Knee Arthroplasty

NCT06980857 | Active Not Recruiting

• 1 other identifier: 3/2022.K-86
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to investigate the effects of bilateral total knee arthroplasty in patients with primary gonarthrosis ERAS protocol compared to standard rehabilitation protocol in the perioperative period to evaluate patients' pain, functional status and satisfaction. The main questions it aims to answer are:

• Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are not effective on pain, function and patient satisfaction.
• Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are effective on pain, function and patient satisfaction. The investigators will be divided and allocated into 3 groups. Group 1 received standard treatment after TKA program will be applied, Group 2 will receive treatment with the ERAS protocol, and Group 3 will add a multimodal physiotherapy program to the ERAS protocol.

Conditions

Osteoartrit; ERAS protokolü; Total Diz Artroplastisi

Keywords

ERAS protokolü; Total diz artroplastisi

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale

  A visual analog scale will be used to measure pain intensity and to monitor pain. This scale is a simple way to measure the intensity of pain. On a 10 cm horizontal scale, '0' means no pain and '10' means the most severe pain. A higher score indicates a worse outcome.

  15 days

• Oxford Knee Score

  It will be used to assess physical function and pain. The Oxford Knee Score (OKS) developed by Dawson et al. is a 12-question reliable and validated questionnaire designed to assess pain and physical function based on the last 4 weeks in patients undergoing total knee arthroplasty. For each question, there are 5 response categories graded from 0 (worst) to 4 (best) points. Scores between 0-19 indicate severe knee arthritis, scores between 20-29 indicate moderate joint function, scores between 30-39 indicate mild joint function and scores between 40-48 indicate normal joint function. Items include pain, movement, limitation, standing up from a sitting position, squatting, walking up and down stairs, sleeping, housework, shopping, personal needs and transportation.

  15 days

• Hospital for Special Surgery

  It will be used to assess pain, function, range of motion, muscle strength, deformity and instability in patients with total knee arthroplasty. It includes both objective and subjective assessment. The evaluation is based on 100 points. A score of 85 and above is considered excellent, 70-84 is considered good, 60-69 is considered fair and 60 and below is considered poor. A high score means that the results are good.

  15 days

• Timed Up and Go Test

  It is done to measure the risk of falling and balance. The test requires a chair, a stopwatch and a 3-meter space. It is an easy test to perform with minimal equipment. The test measures the time between standing up from a sitting chair, walking 3 meters forward at normal speed, turning, walking 3 meters again, and sitting back in the chair. If a person completes this test in more than 12 seconds, they are at risk of falling. A longer duration means a poor outcome

  15 days

• Stair Climbing Test

  A stair climbing test will be performed to assess lower limb strength, stair climbing ability and balance. Participants were asked to climb 9 steps with step intervals between 16-20 cm and the interval was recorded in seconds. A longer time means a poor result.

  15 days

• Assessment of Normal Range of Joint Motion

  Normal range of motion and knee flexion-extension values will be assessed using a universal goniometer. During the measurement, the pivot point was taken as the lateral condyle of the femur and the fixed arm was placed parallel to the lateral midline of the femur. The mobile arm was positioned to follow the fibula. Goniometry is a simple instrument, easy to use and carry. It offers objective evaluation. In addition to assessing NEH, it is also used to determine a treatment program and to determine functional capacity.

  15 days

• Notthingam Health Profile

  The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each subparameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.

  15 days

• Patient Satisfaction Survey

  Participants' satisfaction will be evaluated with this scale After total knee arthroplasty (TKA), participants were asked whether they were satisfied with the surgical procedure. Patients were asked to rate their level of satisfaction on a scale of 1 to 5. Responses ranged from 1 - not at all satisfied to 5 - very satisfied. A high score means a high level of satisfaction. Participants' responses were recorded on a 5-point Likert scale.

  15 days

Study Arms (3)

control group

ACTIVE COMPARATOR

Lower extremity exercises

Other: Control Group

Eras Group

ACTIVE COMPARATOR

Lower extremity exercises and early mobilization

Other: ERAS Group

Multimodal physiotherapy group combined with ERAS protocol

EXPERIMENTAL

Preoperative pain education and home exercise brochure, early postoperative mobilization, lower extremity exercises, NMES current connection to quadriceps muscles in preop and postop process

Other: Multimodal physiotherapy group combined with ERAS protocol

Interventions

Control Group OTHER

In our study, this group will be placed in hyperextension position and immobilized on postoperative day 0. Postop 1-2. Foot pumping exercises, isometric quadriceps exercises, passive knee extension, straight leg raising, 0-40 degree passive knee flexion, partial/full weight ambulation, respiratory exercises and cold application will be performed daily. On postoperative days 3-6 (depending on discharge time), stretching in passive knee extension, active/assisted quadriceps exercises, isometric-isotonic exercise for leg and hip muscles, 90-0 knee extension, 0-90 degree passive knee flexion exercises will be performed.

control group

ERAS Group OTHER

In our study, this group of patients were informed about the surgical procedure to be performed by the orthopedist; detailed information about the postoperative rehabilitation process, prevention of possible complications, preoperative nutrition, smoking and alcohol cessation time will be given. The patient will stop eating solid food 6 hours before the operation and stop drinking fluids 2 hours before the operation. Necessary consultations will be completed before surgery. Preoperative preparation of the patient will be organized according to the ERAS protocol. The patient will be mobilized early, either in bed or in the room, within 6-7 hours after surgery. The exercises of the first group will be continued from the first postoperative day.

Eras Group

Multimodal physiotherapy group combined with ERAS protocol OTHER

In our study, this group of patients who were informed about the surgery by the orthopedist will be examined by the anesthesiologist 1 week before surgery. Patients whose anesthesia preparation is completed will participate in a training program about pain, prevention of postoperative complications, auxiliary devices/equipment and exercises to be used, accompanied by a physiotherapist and a nurse. At the end of the program, patients will be given a 1-week home exercise program prepared by the physiotherapist. NMES device will be connected to the quadriceps muscles for 20 minutes half an hour before surgery, immediately after surgery and every day during hospitalization. Postoperatively, the patient will be mobilized early within 6-7 hours and the knee will be placed in hyperextension position. From the 1st day onwards, the exercises of the first group will be continued.

Multimodal physiotherapy group combined with ERAS protocol

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 60-80,
• Diagnosed with primary gonarthrosis,
• Individuals who decided to undergo total knee arthroplasty were included in the study.

You may not qualify if:

• Those with any neurological disease,
• Received physical therapy in the last 3 months,
• Those with cardiac problems (pacemarker),
• Those with systemic disease,
• Individuals who had revision surgery were not included in the study.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

İstinye Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gül D Yılmaz Yelvar, Prof

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: May 20, 2025
• Study Start: January 2, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)