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Trial record 36 of 662 for:    SMS

The Medacta International SMS Post-Marketing Surveillance 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748408
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Brief Summary:
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.

Condition or disease Intervention/treatment
Arthrosis Traumatic Arthritis Rheumatoid Polyarthritis Congenital Hip Dysplasia Avascular Necrosis of the Femoral Head Device: SMS femoral stem

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
Study Start Date : July 2015
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2028



Primary Outcome Measures :
  1. survivorship of the Medacta SMS femoral stem [ Time Frame: 10-year ]

Secondary Outcome Measures :
  1. clinical performance [ Time Frame: 3, 5, 7 and 10 years ]
    Harris Hip Score

  2. radiographic performance [ Time Frame: 3, 5, 7 and 10 years ]
    presence of radiolucencies

  3. satisfaction [ Time Frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years ]
    Oxford score

  4. quality of life [ Time Frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years ]
    EQ-5D

  5. pattern of bone remodeling [ Time Frame: 6 weeks, 6 months, 1 year ]
    Dual Energy X ray Absorptiometry (DEXA)

  6. stem migration [ Time Frame: 6 weeks, 6 months, 1 and 2 years ]
    Radiostereometric Analysis (RSA)

  7. Adverse events [ Time Frame: up to 10 years ]
    record of adverse event



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals suitable for hip replacement using the Medacta SMS femoral stem
Criteria

Inclusion Criteria:

  • Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
  • In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
  • Scheduled for a primary total hip replacement.

Exclusion Criteria:

  • Active infection
  • Pregnancy
  • Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
  • Grossly distorted anatomy (surgeon's discretion)
  • Osteomalacia where uncemented implant fixation is contraindicated
  • Active rheumatoid arthritis.
  • Osteoporosis
  • Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
  • Muscular atrophy or neuromuscular disease
  • Allergy to implant material
  • Any patient who cannot or will not provide informed consent for participation in the study
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

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): NCT02748408


Contacts
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Contact: Mara Colombo, Eng 0041 91 6966060 colombo@medacta.ch

Locations
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Switzerland
Bürgerspital Solothurn Recruiting
Solothurn, Switzerland, CH-4500
Contact: Näder Helmy, PD Dr.         
United Kingdom
The Elective Orthopaedic Centre (EOC) Recruiting
Epsom, Surrey, United Kingdom, KT18 7EG
Contact: Richard Field, PhD FRCS       richardefield@aol.com   
Sponsors and Collaborators
Medacta International SA

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Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT02748408     History of Changes
Other Study ID Numbers: P01.019.01
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Hip Dislocation
Hip Dislocation, Congenital
Necrosis
Musculoskeletal Diseases
Pathologic Processes
Joint Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities