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

NCT ID: NCT06980857

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2025-09-30

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.

Detailed Description

After total knee arthroplasty (TKA), the patient must receive physical therapy to regain muscle strength, independent movement, and return to activities of daily living (ADL). One of the groups most frequently treated for rehabilitation during post-surgical hospitalization is patients who have undergone total knee arthroplasty surgery. Studies show that post-surgical patients return to their normal daily lives within approximately 6 weeks.However, complications, infections, limitation of the knee joint, additional post-surgical disorders, circulatory problems, vascular nerve problems, pain, rheumatic diseases affect the success of the surgery and the patient's recovery process.

Enhanced Postoperative Recovery Protocols (ERAS) are defined as a multidisciplinary approach that uses a combination of evidence-based practices to improve patient care. The treatment methods included in ERAS protocols are based on the understanding that the healing process can be optimized by protecting patients from catabolism and immune system disorders with factors such as pain management, regulation of fluid therapy, early mobilization and improvement of nutrition.This protocol includes a surgeon, anesthesiologist, nurse, dietitian and physiotherapist. The ERAS protocol considers the patient who will undergo surgery in 3 periods: preoperative period, intraoperative period and postoperative period. Starting with informing the patient before the surgery, bowel preparation, fasting period, alcohol and smoking cessation period, pre-surgical exercise training, surgical method, use of drains or tubes, type of anesthesia, post-surgical fluid intake, switching to carbohydrates, use of analgesia, early removal of tubes and drains. It covers principles such as removal and early mobilization. Looking at the results of research conducted by different disciplines, it is seen that the hospitalization period of patients applied to the ERAS protocol is shortened, their readmissions are reduced and complications are prevented.

Physiotherapy has a very small place in this multidisciplinary team. While it is mentioned that early mobilization plays a key role, it is not emphasized that exercise will accelerate mobilization, increase muscle strength and reduce pain.

Since the place of physiotherapy in the ERAS studies examined in the literature is limited and not comprehensive, the aim of this study is to evaluate the pain, function and patient satisfaction of the pre-op patient education, pain education, exercise, quadriceps muscle stimulation, post-op physiotherapy program applied in addition to the ERAS protocol in patients undergoing total knee arthroplasty. To investigate its effect on

Conditions

Osteoartrit; ERAS protokolü; Total Diz Artroplastisi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

Lower extremity exercises

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: 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.

Eras Group

Lower extremity exercises and early mobilization

Group Type: ACTIVE_COMPARATOR

ERAS Group

Intervention Type: 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.

Multimodal physiotherapy group combined with ERAS protocol

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

Group Type: EXPERIMENTAL

Multimodal physiotherapy group combined with ERAS protocol

Intervention Type: 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.

Interventions

Control Group

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.

Intervention Type: OTHER

ERAS Group

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.

Intervention Type: OTHER

Multimodal physiotherapy group combined with ERAS protocol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gül D Yılmaz Yelvar, Prof

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Locations

İstinye Üniversitesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

3/2022.K-86

Identifier Type: -

Identifier Source: org_study_id