NCT06989229

Brief Summary

This prospective observational study will assess the impact of standardized perioperative nutritional care on postoperative outcomes in patients undergoing elective total hip (THA) or knee arthroplasty (TKA) at the First Department of Orthopaedic Surgery, St. Anne's University Hospital in Brno. The protocol includes preoperative patient education, nutritional risk screening, and carbohydrate loading up to two hours before anesthesia, followed by early postoperative refeeding. Data collection will include demographic and surgical variables, nutritional status, carbohydrate intake, and the occurrence of intra- and postoperative complications, including infection and delayed wound healing. As perioperative nutritional care is part of routine clinical practice, the study requires no additional interventions or resources. Results will provide evidence on the effectiveness of structured nutritional support in enhancing recovery and reducing complications after joint replacement surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2025

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Progress38%
May 2025Dec 2027

Study Start

First participant enrolled

May 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

May 13, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative Complications

    Measurement: Number and type of complications documented in the patient's medical records during hospitalization and up to discharge, including infections, aspiration, and other clinical events.

    2 weeks postoperatively

Secondary Outcomes (2)

  • Length of Hospital Stay

    2 weeks postoperatively

  • Wound Healing Status

    2 weeks postoperatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients to undergo elective total hip and knee arthroplasty

You may qualify if:

  • Elective total hip replacement Elective total knee replacement

You may not qualify if:

  • Hip fracture Diabetes mellitus 1 Insulinotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Brno, Czechia, 60200, Czechia

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Vasileios Apostolopoulos, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 25, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations