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Symax International Study

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ClinicalTrials.gov Identifier: NCT03469687
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
Vejle Hospital
Stryker Orthopaedics
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Prosthesis Durability Device: Symax uncemented hip stem Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study
Actual Study Start Date : November 2, 2004
Actual Primary Completion Date : October 11, 2010
Actual Study Completion Date : October 11, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Symax uncemented hip stem
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.
Device: Symax uncemented hip stem



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03469687    
Other Study ID Numbers: METC 04-112
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Prosthesis Failure
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes