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Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem (SMF-S&E)

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: NCT02471703
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.

Condition or disease Intervention/treatment
Joint Diseases Device: Total hip arthroplasty

Detailed Description:
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.

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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
Study Start Date : September 2010
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SMF mini-stem hip replacement recipient
Received the device via total hip arthroplasty
Device: Total hip arthroplasty
Total hip arthroplasty
Other Name: Total hip replacement




Primary Outcome Measures :
  1. Revision of the study device [ Time Frame: Discharge through 10 years ]
    Instances of required revision of the study device

  2. Device related Adverse Events [ Time Frame: Implant through 10 years ]
    surgical, device-related, death and serious adverse events will be analyzed

  3. Harris Hip Score [ Time Frame: Baseline through 10 years ]
    Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion

  4. HOOS Questionnaire [ Time Frame: Baseline through 10 years ]
    Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Patients requiring total hip replacement.
Criteria

Inclusion Criteria:

  • Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
  • Patient is of legal age to consent, is skeletally mature and at least 18 years old.
  • Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
  • Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.

Exclusion Criteria:

  • Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
  • Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI > 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.
  • Patient is over the age of 75.
  • Skeletal immaturity: patients must be at least 18 years at the time of the operation.
  • Patient has an active, local infection that would lead to increased bone resorption.
  • Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities.
  • Known sensitivity to materials of the implant.
  • Patient is pregnant or plans to be come pregnant during the course of the study.
  • Patient is a prisoner.

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): NCT02471703


Locations
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Belgium
ZNA Middleheim
Berchem, Belgium, 2600
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C1R6
Canada, Quebec
Hopital Maisonneuve Rosemont, Hmr
Montreal, Quebec, Canada, 5701
CHUQ-L'Hôtel-Dieu de Québec
Quebec City, Quebec, Canada, G1R 2J6
Germany
St. Vincenz Hospital
Brakel, Germany, 22024
Brüderkrankenhaus St. Josef
Paderborn, Germany, 33098
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Director: Andy Weymann, MD Chief Medical Officer - Advanced Surgical Devices
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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT02471703    
Other Study ID Numbers: CR-132
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Keywords provided by Smith & Nephew, Inc.:
Total Hip Arthroplasty
Total Hip Replacement
Inflammatory Joint Disease
Non-Inflammatory Joint Disease
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases