Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT05042492
Eligibility Criteria:
Inclusion Criteria:
* Primary TKA planned for degenerative OA
* Subjects must be discharged to home environment and be able to independently perform the activities of daily life
* Obtain a written informed consent
Exclusion Criteria:
* TED stockings, Dauerbinde, other compressive bandages
* Mechanical foot pump
* Cooling device type 'Game Ready'
* Posttraumatic OA of the knee
* History of DVT / Flebitis / Pulmonary embolism
* Surgical treatment of venous insufficiency \<1y prior to TKA surgery
* Neurological deficit of lower limbs
* Current sciatic irradiating pain in lower limbs
* History of lumbar fusion
* Knee Arthroscopy of the involved limb \<6m prior to TKA surgery
* Any per-operative complication related to the TKA procedure (bleeding, fracture, vascular injury, cardiac complication, pulmonary complication)
* In case of a release during the TKA procedure
* Any per-operative (e.g. epidural catheter, urethral catheter, intra articular catheter) or post-operative procedure that might interfere with the rehabilitation during and after hospitalization
* Any scheduled surgery in the 3 months following the reference surgery;
* Any significant medical condition (e.g. Parkinson's disease, multiple sclerosis, cerebral vascular accident) that might interfere with the rehabilitation
* Any significant psychiatric disorders, active alcohol/drug abuse
* Subject is either pregnant or interested in becoming pregnant during the duration of the study
* Subjects who are currently involved in any investigational drug or device study or have been enrolled in such study within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05042492
Study Brief:
Protocol Section:
NCT05042492