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Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04172129
Recruitment Status : Completed
First Posted : November 21, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )

Brief Summary:
The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

Condition or disease Intervention/treatment
Primary and Secondary Coxarthrosis Dysplasia Coxarthrosis Post-traumatic Necrosis of the Femoral Head Device: Total Hip Arthroplasty

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
Actual Study Start Date : April 26, 2011
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NANOS
NANOS™ Neck Preserving Hip Stem
Device: Total Hip Arthroplasty



Primary Outcome Measures :
  1. Evaluation of migration pattern of the Nanos stem [ Time Frame: 2 years ]
    Measuring migration used the model-based RSA method

  2. Change in quality of life [ Time Frame: 2 years ]

    Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score

    • Minimum Value: 0 (worst outcome)
    • Maximum Value: 100 (best outcome)


Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 2 years ]
    Investigator assessed outcome score Minimum: 0 (worst outcome) Maximum: 100 (best outcome)

  2. University of California, Los Angeles (UCLA) scale [ Time Frame: 2 years ]

    Score rating the patient's current activity level

    • Minimum: 1 (wholly inactive subject)
    • Maximum: 10 (totally active subject)

  3. Pain Visual Analogue Scale [ Time Frame: 2 years ]

    Score representing patient's current pain intensity

    • Minimum: 0 (no pain)
    • Maximum: 100 (very severe pain)

  4. Postel Merle d'Aubigné-Score [ Time Frame: 2 years ]

    Score grading the functional value of the hip

    • Minimum: 0 (worst outcome)
    • Maximum: 6 ( best outcome)

    Grading is done in each of the three dimensions: pain, mobility and ability to walk.


  5. Hip Disability and Ostheoarthritis Outcome Score [ Time Frame: 2 years ]

    Patient reported outcome

    • Minimum: 0 (best outcome)
    • Maximum: 96 (worst outcome)

  6. Radiographic Evaluation [ Time Frame: 2 years ]
    Evaluation of radiographic images regarding implant position, implant fixation, heterotopic ossifications (HO), radiolucencies, osteolysis, atrophy and hypertrophy

  7. Number of adverse events [ Time Frame: 2 years ]
    Collection of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients identified in the primary care clinic with need for total hip arthroplasty
Criteria

Inclusion Criteria:

  • Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
  • Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
  • Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
  • Subject was 30 to 65 (inclusive) years of age at time of surgery.

Exclusion Criteria:

  • Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
  • Subject had a local or systemic infection.
  • Subject had previously diagnosed osteoporosis.
  • Subject had a femoral neck angle of >145°.
  • Subject had a femoral neck angle of <125°.
  • Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
  • Subject had a documented allergy against elements of the implanted device.
  • Subject had a neurological disease with changed motor function.
  • Subject was pregnant.
  • Subject had a Body Mass Index (BMI) > 30.
  • Subject suffered from alcoholism or addictive disorders.
  • Subject needed a revision hip arthroplasty.
  • Subject had an insufficient command of the language to understand patient information and consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172129


Locations
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Germany
Orthopädische Klinik der Medizinischen Hochschule Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
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Principal Investigator: Henning Windhagen, Prof. Dr. med. Orthopädische Klinik der Medizinischen Hochschule Hannover
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Responsible Party: Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier: NCT04172129    
Other Study ID Numbers: R11014-3-D
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG ):
Nanos
THA
MBRSA
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Necrosis
Pathologic Processes
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases