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Completed

NCT Number: NCT03469687

Symax International Study

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Durability Prosthesis Failure Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symax uncemented hip stem

Device

Primary outcomes

  1. Change of Harris Hip Score (HHS) during follow-up

    Time frame: 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 outcomes

  1. Radiographic evaluations

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Stryker Orthopaedics
  • Vejle Hospital

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2018
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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