- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394582
Preoperative Optimization Before Total Hip or Knee Replacement Surgery (PrOpE)
Preoperative Optimization Before Total Hip or Knee Replacement Surgery - a Controlled, Randomized, Single-blind Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helmut Raab, MD
- Phone Number: +435050480833
- Email: helmut.raab@tirol-kliniken.at
Study Contact Backup
- Name: Christine Eckhardt, MD, PhD
- Email: christine.eckhardt@i-med.ac.at
Study Locations
-
-
Tyrol
-
Innsbruck, Tyrol, Austria, 6020
- Recruiting
- Medical University Innsbruck
-
Contact:
- Barbara Sinner, MD, PhD
- Phone Number: +43 50 504 28503
- Email: mui-sponsor@i-med.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Care Group
Participants receive usual medical care before and after surgery.
|
|
|
Experimental: Intervention Group
In addition to standard care, participants receive an individualised preparation programme over several weeks before surgery. This programme may include:
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: From enrollment to the postoperative discharge from the hospital (9 to 25 weeks).
|
Length of hospital stay (intensive care unit, recovery room, observation unit, general ward; date of discharge readiness and actual discharge)
|
From enrollment to the postoperative discharge from the hospital (9 to 25 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Sinner, MD, MBA, Medical University Innsbruck
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-Nr. 1193/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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