NCT03469687

Symax International Study

5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.

Conditions

• Hip Osteoarthritis
• Prosthesis Durability

Interventions

Type	Name	Description
DEVICE	Symax uncemented hip stem

Timeline

• Start date: 2004-11-02
• Primary completion: 2010-10-11
• Completion: 2010-10-11
• First posted: 2018-03-19
• Last updated: 2018-03-19