Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology

NCT03822247 | Unknown

• 1 other identifier: KBC Zagreb Surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.

Conditions

Hip Fractures; Knee Fracture; Hip Arthritis; Knee Arthritis

Keywords

Recovery; Patient reported outcome measures; Hip fracture; Hip arthritis; Knee fracture; Knee arthritis

Outcome Measures

Primary Outcomes (2)

• Early Postoperative Complications

  Occurrence of early complications: * Dislocation or malpositioning of joint replacement * Neurological deficit * Need for blood transfusion * Postoperative delirium * Nausea or vomiting * Pneumonia * Headache * Wound dehiscence, secretion, inflammation, bleeding

  48 hours after surgery

• Late Postoperative Complications

  Occurrence of late complications: * Wound infection, healing by secundam * Decubitus * Fracture of joint replacement * Aseptic loosening of hip joint replacement * Infection of joint replacement * Thromboembolism * Need for a revision

  10 days after surgery

Secondary Outcomes (5)

• Readmission rates

  30 days after surgery

• Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  2 days, 60 days after surgery, 90 days after surgery

• Pain assessment using Visual Analog Scale (VAS)

  1 day, 2 days, 60 days after surgery, 90 days after surgery

• Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)

  baseline, 2 days, 60 days after surgery, 90 days after surgery

• Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)

  3 days after surgery

Study Arms (2)

Multidisciplinary Recovery Program

EXPERIMENTAL

Two cohorts of patients will randomly be placed in either experimental od no intervention group. Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.

Procedure: Multidisciplinary Recovery Program

Conventional Perioperative Care

NO INTERVENTION

Patients undergoing conventional care

Interventions

Multidisciplinary Recovery Program PROCEDURE

Preoperative care: * Patient's education * Providing respiratory training * Assessment of nutritional status * Application of compression stockings * Thromboembolism prophylaxis by low molecular weighted heparin * Induction of hemodynamic support 12 hours before the surgery * Oral carbohydrate solution loading until 2 hours before the surgery Intraoperative care: * Maintaining normothermia * Multimodal prevention of postoperative nausea and vomiting * Use of spinal anesthesia * Prevention of excessive blood loss * Local anesthetic infiltration Postoperative care: * Active pain control * Early mobilization * Early onset of oral nutrition * Early delirium detection * Application of compression stockings

Multidisciplinary Recovery Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fracture od proximal femur or knee fracture requiring surgery
• Hip or knee arthrosis requiring joint replacement
• American Society of Anesthesiologists (ASA) score II or III
• Ability to provide informed consent

You may not qualify if:

• Severe cognitive impairment
• Pregnancy
• End stage of malignant disease
• Decompensated heart or liver disease

Sponsors & Collaborators

• Klinički Bolnički Centar Zagreb: lead

Study Sites (1)

KBC Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Knee Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Knee Injuries

Study Officials

• Nikica Daraboš

  Head of Department of traumatology, bone and joint surgery

  STUDY CHAIR

Central Study Contacts

Nikica Daraboš

CONTACT

+385 1 2388 203; nikica.darabos@kbc-zagreb.hr

Sara Medved

CONTACT

+385 1 2388 394; smedved@kbc-zagreb.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 30, 2019
• Study Start: December 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)