Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem

NCT04913623 | Unknown

• 1 other identifier: 03/2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The cemented femoral stem have impact on increase on systemic parameters. Evaluation of the level of histamine, C-reactive protein (CRP) and leukocytes formula, IL1b, TNF alpha, IL6 and the reflection of changes of these parameters in the intra-operative course of hip replacement.

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (6)

• Change of systemic parameters during and after hip replacement (Histamine)

  Analysis of the impact of cement in different laboratory parameters such as histamine

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

• Change of systemic parameters during and after hip replacement (CRP)

  Analysis of the impact of cement in different laboratory parameters such as C-reactive protein (CRP)

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

• Change of systemic parameters during and after hip replacement (Leukocytes formula)

  Analysis of the impact of cement in different laboratory parameters such as changes of leukocytes formula

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

• Change of systemic parameters during and after hip replacement (IL1b)

  Analysis of the impact of cement in different laboratory parameters such as IL1b

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

• Change of systemic parameters during and after hip replacement (TNF alpha)

  Analysis of the impact of cement in different laboratory parameters such are TNF alpha

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

• Change of systemic parameters during and after hip replacement (IL6)

  Analysis of the impact of cement in different laboratory parameters such as IL6.

  The measurement of these laboratory parameters 5 minutes before and 10 minutes after surgical procedures will reflect the impact of cements in the eventual post-surgical complications, such are embolism and other complications.

Secondary Outcomes (3)

• Difference of arterial pressure

  The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation

• Difference of changes of Leukocyte formula

  The blood will be taken from patience 1 hour before and Post Operative Day One

• Difference of SpO2

  The changes will be measured 5 minutes before implantation and during first 10 minutes after implantation]

Study Arms (2)

Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA

Procedure: Hip Replacement

Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA

Procedure: Hip Replacement

Interventions

Hip Replacement PROCEDURE

The hip replacement surgery is when a damaged hip is replaced with artificial one

Also known as: Hip replacement surgery, Arthroplasty

Correlation of intramedullary pressure and systemic inflammatory parameters in cemented THA; Correlation of intramedullary pressure and systemic inflammatory parameters in non cemented THA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are from the waiting list for surgery. All are included in the study with their consent The femoral component cemented or non-cemented is realized based on bone quality, age and its testing during surgery.

You may qualify if:

• All patients willing to participate who underwent cemented and uncemented THA,
• With no limit on age

You may not qualify if:

• Periprosthetic fractures,
• Pathological fractures
• THA revision
• ASA IV

Sponsors & Collaborators

• University Clinical Centre of Kosova: lead

Study Sites (1)

University Clinical Center of Kosovo

Pristina, 10000, Kosovo

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Evaluation of the level of histamine, C-reactive protein (CRP) and leukocytes formula, IL1b, TNF alpha, IL6 and the reflection of changes of these parameters in the intra-operative course of hip replacement.

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip; Arthroplasty

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Skender Ukaj, MD

CONTACT

0038344603609; skender.ukaj@uni-gjk.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Orthopaedics and Trauma

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: June 4, 2021
• Study Start: March 23, 2021
• Primary Completion: May 23, 2021
• Study Completion: June 23, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-05

Locations

KO (1)