Symax International Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03469687

Enrollment

Registered

2018-03-19

Start date

2004-11-02

Completion date

2010-10-11

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Prosthesis Durability

Brief 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.

Interventions

DEVICESymax uncemented hip stem

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change of Harris Hip Score (HHS) during follow-up	Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years	A hip specific functional score

Secondary

Measure	Time frame	Description
Radiographic evaluations	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	Radiographic evaluations per Gruen zone and comparison between two assessment teams

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026