A Cement Compression Device for cemented TKA

Completed

• Conditions: Knee osteoarthritis; knee wear; 10023213

• Registration Number: NL-OMON49376
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

- 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

Exclusion Criteria

- Rheumatoid arthritis or other forms of inflammatory disease
- 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
prosthesis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Charcot's disease
- Previous knee surgery except arthroscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the penetration and distribution of the cement<br /><br>into the bone of the proximal tibia, measured with CT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameter is the measured operation time.</p><br>