Symax International Study

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Prosthesis Durability; Hip Osteoarthritis

Treatments: Device: Symax uncemented hip stem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03469687

METC 04-112

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Symax uncemented hip stem

Other group

Description:

The Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem.

Treatment:

Device: Symax uncemented hip stem