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Recruiting NCT07655921

ERAS in Total Knee Arthroplasty: a Randomized Controlled Trial

No phase Interventional ERAS TKA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ERAS PROTOCOL.
Who it may be relevant to
Registry conditions: ERAS, TKA. Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Tria

Overview

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.

Interventions

  • Behavioral ERAS PROTOCOL
    ERAS IMPLEMENTATION IN TKA PATIENTES

Primary outcome measures

  • TIME TO ORAL INTAKE [Time frame: Baseline]
  • Length of hospital stay [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Pakistan · 1 center
  • Liaquat National Hospital — Karachi

Publications

  • 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. PMID 34625057

Identifiers

NCT: NCT07655921 · 1197-2025-LNH-ERC · ETHICAL REVIEW COMMITTEE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗