Clinical trial NCT06980857: The Effect of the Physiotherapy Program Added to the ERAS Protocol in Patients With Total Knee Arthroplasty
Official title: Examining the Effect of the Physiotherapy Program Added to the ERAS Protocol on Pain, Function and Patient Satisfaction in Patients With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoartrit
ERAS protokolü
Total Diz Artroplastisi
Keywords: ERAS protokolü
Total diz artroplastisi
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 15 days
measure: Oxford Knee Score
timeFrame: 15 days
measure: Hospital for Special Surgery
timeFrame: 15 days
measure: Timed Up and Go Test
timeFrame: 15 days
measure: Stair Climbing Test
timeFrame: 15 days
measure: Assessment of Normal Range of Joint Motion
timeFrame: 15 days
measure: Notthingam Health Profile
timeFrame: 15 days
measure: Patient Satisfaction Survey
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstinye Üniversitesi
Study officials:
affiliation: Istinye University
name: Gül D Yılmaz Yelvar, Prof
role: PRINCIPAL_INVESTIGATOR
References: