A Cement Compression Device for Cemented TKA
- Conditions
- Knee osteoarthritis, knee wear
- Registration Number
- NL-OMON25335
- Lead Sponsor
- Vakgroep Orthopedie RdG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Non-inflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis;
- Traumatic arthritis;
- The need for a tibia component size 4, 5 or 6 (NexGen Legacy, Zimmerbiomet) during surgery.
Patients must additionally meet all of the following criteria:
- Age > 18 years;
- Patient is willing to participate;
- Patient is able to speak and write Dutch;
- Patient qualifies for TKP based on medical history and physical examination;
- Patient is able and willing to provide written informed consent.
- Rheumatoid arthritis or other forms of inflammatory disease(s);
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
- Insufficient bone stock to provide adequate support and/or fixation to the prothesis;
- Metabolic disorders which may impair bone formation;
- Osteomalacia;
- Charcot's disease;
- Previous knee surgery exept arthroscopy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameters are the penetration and distribution of the cement into the bone of the proximal tibia, measured with CT.
- Secondary Outcome Measures
Name Time Method The secondary parameter is the measured operation time.