Information sheet on the clinical study - ENABLE Hip Study

Main Indication

You need a unilateral hip replacement and would like to improve your recovery after surgery. This includes early mobilization after surgery and prevention of thrombosis (blood clots). 

Study name (study type)

ENABLE-HIP Study (randomized)

Study sponsor

University Medical Center of Johannes Gutenberg University Mainz

Registration number

EU trial number: 2023-507490-18-00

FOR SKIM READERS:

This study aims to compare whether patients who undergo hip replacement surgery experience a faster recovery overall with early mobilization and a shortened course of the anticoagulant Xarelto (blood thinner) lasting 10 days, compared to the standard treatment of 28–35 days.

DETAILED INFORMATION:

Following hip replacement surgery, the current standard treatment involves taking an anticoagulant (blood thinner) for a period of 28 to 35 days. 

Taking anticoagulants is also associated with risks, such as uncontrolled bleeding. 

Preliminary results from scientific studies and clinical experience indicate that a shorter course of anticoagulants combined with early mobilization after surgery has no adverse effects on the risk of thrombosis and may be beneficial overall for patients’ rapid recovery.

Study Title

Improved Recovery and Shortened Anticoagulation for Thrombosis Prevention After Primary Hip Arthroplasty 

Which conditions are addressed in the study?

Prevention of thrombosis following hip replacement surgery

Background on the study medication

Xarelto is routinely used for thrombosis prevention following hip replacement surgery. The drug has been approved for this type of treatment since 2008. 

Study Schedule

This study will last approximately 3 months, during which time there will be five visits. 

There will be two treatment groups, and the patient will be randomly assigned (a process called randomization) to one of the groups. This means either the group that receives Xarelto (a blood thinner) until day 35 after surgery, in accordance with current treatment standards, or the experimental group that receives Xarelto for only 10 days and a placebo from day 11 through day 35. 

Inclusion Criteria

• Planned hip replacement surgery

Exclusion criteria

• You may not participate in this clinical trial if you are currently participating in other interventional clinical trials

• Pregnant women may not participate in this study, as Xarelto must not be taken during pregnancy. 

   

Your contacts: Investigators at the center and contact information

Dr. Manfred Krieger, Chief of Orthopedics

Responsible staff members in the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032