Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)

Arthroplasty, Replacement, Knee Clinical Trial

— POWER2  

Official title:

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol National Audit of Complications Following Elective Total Hip or Knee Replacement Within or Without an Enhanced Recovery After Surgery Protocol (POWER2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570944
• Other study ID #: RedGerm02
• Status: Recruiting
• Start date: October 22, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: March 2019
• Source: Grupo Español de Rehabilitación Multimodal
• Contact: Javier Ripollés-Melchor, MD
• Phone: 34620965143
• Email: ripo542[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Methods National audit of a 60-day prospective observational cohort in the that the pre-defined postoperative complications at 30 days of follow-up in adult patients electively undergoing hip replacement surgery (HRS) or knee replacement surgery (KRS) with or without a program of Enhanced Recovery (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)

Research Places Spanish Hospitals where these surgical interventions are performed usually

Objectives To determine the incidence of Postoperative Complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the Hospital Stay and on postoperative complications including 30-day mortality

Sample Size For an alpha error of 5% (95% confidence and an accuracy of 3% and estimating a number of patients with complications of 50%, the calculation of sample size yields 3012 patients, although the final sample size may be smaller depending on the proportion of complications detected.

Inclusion criteria Patients over 18 undergoing elective HRS or KRS PTC regardless of its affiliation to a ERAS program and the level of compliance with protocol (from 0-100%)

Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not distributed normally. The comparisons of continuous variables are performed by one-way ANOVA or the Mann-Whitney test, depending on proceed A univariate analysis will be carried out to test the factors associated with postoperative complications, hospital stay and death in Hospital. Univariate analyzes and logistic regression models will be constructed Hierarchical multivariate to identify the factors associated in a independent with these results and to adjust the differences in the factors of confusion. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3012
• Est. completion date: March 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• All patients over 18 who undergoing HRS or KRS with or without an ERAS intensified recovery program with any level of protocol compliance (0-100%) Surgeries planned by inclusion criteria

• Total elective knee replacement surgery(primary)

• Total elective hip replacement surgery (primary)

Exclusion Criteria:

• Patients undergoing emergency surgery.

• Partial prostheses

• Replacement of prosthesis

• Patients who decline to participate

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• HRS, KRS
Elective HRS or KNR in adult patients, with any ERAS compliance

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Rehabilitación Multimodal

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Berend KR, Lombardi AV Jr, Mallory TH. Rapid recovery protocol for peri-operative care of total hip and total knee arthroplasty patients. Surg Technol Int. 2004;13:239-47. Review. — View Citation

Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y. — View Citation

Healy WL, Iorio R, Pellegrini VD, Della Valle CJ, Berend KR. Reply to the Letter to the Editor: Complications of Total Hip Arthroplasty: Standardized List, Definitions, and Stratification Developed by the Hip Society. Clin Orthop Relat Res. 2016 Jun;474(6 — View Citation

Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ERAS overall compliance	ERAS compliance according to (4)	30 day
Primary	30 day postoperative complications	Complications are defined according to Standards for definitions and use of outcomes for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions (1), the standardized list and definitions of the Knee Society (2) and Standardized List , Definitions, and the Stratification Developed by The Hip Society (3)	30 days
Secondary	Mortality	30 day mortality	30 day
Secondary	Hospital Stay	Primary hospital stay after surgery	30 day