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Recruiting NCT07394582

Preoperative Optimization Before Total Hip or Knee Replacement Surgery

No phase Interventional Prehabilitation Preoperative Care

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: Prehabilitation.
Who it may be relevant to
Registry conditions: Prehabilitation, Preoperative Care. Basic parameters: 18 years — 99 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
Austria
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

Preoperative Optimization Before Total Hip or Knee Replacement Surgery - a Controlled, Randomized, Single-blind Study

Overview

Preoperative Optimisation prior to Hip and Knee Arthroplasty (PrOpE) Many patients scheduled for planned hip or knee replacement surgery have health conditions that may affect recovery, such as reduced physical fitness, nutritional problems, multiple medications, or increased stress and anxiety. These factors can increase the risk of complications and delay recovery after surgery. The PrOpE study examines whether a structured preparation programme before surgery, known as preoperative optimization or prehabilitation, can be safely implemented and may support recovery after hip or knee replacement. Aim of the study The main aim is to assess the feasibility of a comprehensive preoperative optimisation programme and to explore its potential effects on recovery and health outcomes. The results will help improve future care for patients undergoing major orthopaedic surgery. Who can participate? Adult patients scheduled for elective total hip or knee replacement surgery who are classified as ASA \>2, aged between 18 and 99 years old and without a severe cognitive impairment. Participation is voluntary. Study design A total of 180 participants will be included and randomly assigned to one of two groups: • Standard Care Group: Participants receive usual medical care before and after surgery. • Intervention Group: In addition to standard care, participants receive an individualised preparation programme over several weeks before surgery. This programme may include: * Personalised physical exercise * Nutritional assessment and advice * Support for stress, pain, and mental well-being * Review of regular medications Some elements may be delivered at home or via telemedicine, depending on individual needs. What information is collected? The study evaluates recovery after surgery, including complications, length of hospital stay, physical function, quality of life, and use of health care services. Questionnaires, physical tests, and blood samples are used to better understand health status before and after surgery. Risks and benefits The study involves low additional risk. All measures are adapted to individual abilities and supervised by trained professionals. The main burden is the additional time required for participation. Participants in the optimisation group may benefit from improved preparation for surgery. The study also contributes to improving care for future patients.

Detailed description

Preoperative Optimisation prior to Hip and Knee Arthroplasty (PrOpE) Many patients scheduled for planned hip or knee replacement surgery have health conditions that may affect recovery, such as reduced physical fitness, nutritional problems, multiple medications, or increased stress and anxiety. These factors can increase the risk of complications and delay recovery after surgery.

The PrOpE study examines whether a structured preparation programme before surgery, known as preoperative optimization or prehabilitation, can be safely implemented and may support recovery after hip or knee replacement.

Aim of the study The main aim is to assess the feasibility of a comprehensive preoperative optimisation programme and to explore its potential effects on recovery and health outcomes. The results will help improve future care for patients undergoing major orthopaedic surgery.

Who can participate? Adult patients scheduled for elective total hip or knee replacement surgery who are classified as ASA \>2, aged between 18 and 99 years old and without a severe cognitive impairment. Participation is voluntary.

Study design

A total of 180 participants will be included and randomly assigned to one of two groups:

• Standard Care Group: Participants receive usual medical care before and after surgery.

• Intervention Group:

In addition to standard care, participants receive an individualised preparation programme over several weeks before surgery. This programme may include:

* Personalised physical exercise * Nutritional assessment and advice * Support for stress, pain, and mental well-being * Review of regular medications Some elements may be delivered at home or via telemedicine, depending on individual needs.

What information is collected? The study evaluates recovery after surgery, including complications, length of hospital stay, physical function, quality of life, and use of health care services. Questionnaires, physical tests, and blood samples are used to better understand health status before and after surgery.

Risks and benefits The study involves low additional risk. All measures are adapted to individual abilities and supervised by trained professionals. The main burden is the additional time required for participation. Participants in the optimisation group may benefit from improved preparation for surgery. The study also contributes to improving care for future patients.

Interventions

  • Other Prehabilitation
    * Personalised physical exercise * Nutritional assessment and advice * Support for stress, pain, and mental well-being * Review of regular medications Some elements may be delivered at home or via telemedicine, depending on individual needs.

Primary outcome measures

  • Length of hospital stay [Time frame: From enrollment to the postoperative discharge from the hospital (9 to 25 weeks).]

Eligibility criteria

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status classification ≥ 3
  • Age between 18 and 99 years
  • All sexes
  • Elective total hip or knee replacement with a waiting period of ≥ 8 weeks between surgical indication and surgery
  • Ability to understand the nature, content, and procedures of the study and to provide written informed consent
  • Written informed consent obtained prior to any study-related procedure

Exclusion criteria

  • Pregnancy or active breastfeeding
  • Severe trauma or major blood loss within 14 days prior to enrollment
  • Participation in another pharmacological or interventional clinical study
  • Contraindications to physical training
  • Pre-existing diagnosis of moderate to severe dementia

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
Single blind
Primary purpose
Prevention

Study locations

Austria · 1 center
  • Medical University Innsbruck — Innsbruck

Identifiers

NCT: NCT07394582 · EK-Nr. 1193/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗