NCT07655921

Brief Summary

Total knee arthroplasty(TKA) is the most commonly performed procedure for advanced knee osteoarthritis. Enhanced recovery after surgery (ERAS) protocols are primarily implemented to reduce perioperative stress and improve surgical and functional outcomes. Evidence of the implementation of ERAS protocols in low to middle-income countries like Pakistan is limited. This study aims to evaluate the effectiveness of ERAS protocols in TKA patients. A prospective randomized controlled trial study was conducted within our institute from July 2025 to January 2026, in which a total of 239 patients who underwent primary bilateral TKA, of which 121 patients received conventional treatment and protocols, and a study group with 120 participants were managed according to the ERAS protocol. Patients were in the 50-70 years age bracket, and had an American Society of Anesthesiologists grade I-III. The protocol included preoperative physiotherapy, reduced fasting time, multimodal anesthesia, perioperative tranexamic acid, early ambulation and early oral intake. Postoperative outcomes included time to oral intake, postoperative nausea and vomiting, time to mobilization, length of hospital stay, range of motion and Hospital for Special Surgery score.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 31, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

May 31, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • TIME TO ORAL INTAKE

    DURATION AFTER WHICH NPO WAS BROKEN

    Baseline

  • Length of hospital stay

    STAY IN THE HOSPITAL AFTER THE INTERVENTION

    through study completion, an average of 1 year

Study Arms (2)

control group

NO INTERVENTION

the group will receive conventional treatment protocol

study group

EXPERIMENTAL

eras protocol implementation in this group

Behavioral: ERAS PROTOCOL

Interventions

ERAS PROTOCOLBEHAVIORAL

ERAS IMPLEMENTATION IN TKA PATIENTES

Also known as: STUDY GROUP
study group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA grade of 1-3 BMI was restricted to less than 30 kg/m²

You may not qualify if:

  • ASA grade of IV or higher uncontrolled comorbidities not consenting to the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (1)

  • Wei B, Tang C, Li X, Lin R, Han L, Zheng S, Xu Y, Yao Q, Wang L. Enhanced recovery after surgery protocols in total knee arthroplasty via midvastus approach: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Oct 8;22(1):856. doi: 10.1186/s12891-021-04731-6.

Central Study Contacts

DR MOHAMMAD ZEESHAN HAIDER, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 18, 2026

Study Start

May 13, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations