Symax International Study

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469687
• Other study ID #: METC 04-112
• Status: Completed
• Phase: N/A
• First received: January 15, 2018
• Last updated: March 16, 2018
• Start date: November 2, 2004
• Est. completion date: October 11, 2010

Study information

• Verified date: January 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 11, 2010
• Est. primary completion date: October 11, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.

Exclusion Criteria:

• Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Prosthesis Durability
• Prosthesis Failure

Intervention

Device:
• Symax uncemented hip stem

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Stryker Orthopaedics, Vejle Hospital

References & Publications (2)

ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986. — View Citation

ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Harris Hip Score (HHS) during follow-up	A hip specific functional score	Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years
Secondary	Radiographic evaluations	Radiographic evaluations per Gruen zone and comparison between two assessment teams	Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again