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A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System

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ClinicalTrials.gov Identifier: NCT03646513
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years post-surgery.

Condition or disease Intervention/treatment
Total Hip Arthroplasty (THA) Device: SMF Short Modular Femoral Hip System

Detailed Description:

This is a single arm, consecutive series study to collect relevant clinical, laboratory and radiological data in up to 26 subjects, who have been implanted with the SMF Short Modular Femoral Stem THA system at 1 site in Australia.

The Baseline visit will be determined as the first visit to site after Ethics approval. This will be approximately 8-9 years post implant. Enrolled subjects will be followed up to 20 years post SMF implant.

Eligible patients will be contacted and patient status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 12 year on-site follow-up visits for which they will provide written informed consent. Subjects who are lost to follow-up, deceased or are unwilling/unable to participate in the prospective study will be noted in the subject files and this data will be captured for analysis of study results. Data will be collected on the operative date, and implant status.

Post Baseline, the study will allow for metal ion assessments every 3 years for asymptomatic subjects and annual assessments for subjects with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the SMF implant, having ruled out all other probable causes for the subject. If the subject has elevated whole blood cobalt or chromium (defined as >7ppb) a MARS MRI or CT will be obtained. These types of imaging techniques are aimed at detecting inflammatory degenerative evolution of peri articular soft tissues including pseudo-tumours. A functional Questionnaire, HOOS JR Questionnaire will be completed at all patient site visits.

Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.


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Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030

Group/Cohort Intervention/treatment
SMF Short Modular Femoral Stem Implanted Subjects
Subjects who have been implanted with the SMF Short Modular Femoral Stem for primary total hip arthroplasty.
Device: SMF Short Modular Femoral Hip System
Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.




Primary Outcome Measures :
  1. Metal Ion Analysis as a safety assessment [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    All subjects at Baseline and every three years afterwards will have whole blood collected for metal ion testing of whole blood cobalt and chromium. Symptomatic subjects with pain, swelling, and/or functional limitations if assessed by the PI to be related to the implant will have whole blood collected for metal ion testing of cobalt and chromium annually.

  2. MARS MRI/CT [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    Subjects with whole blood cobalt and/or chromium > 7 ppb will have MARS MRI (or CT if MRI is contraindicated) performed. This is used to detect pseudotumors, abductor muscle atrophy, and tendinous pathology in patients with painful metal-on-metal (MOM) hip arthroplasty.


Secondary Outcome Measures :
  1. SMF Short Modular Femoral Stem Revision [ Time Frame: To be captured at any time during the study duration of 12 years from the point of informed consent signing. ]
    Revision of any component of the SMF Short Modular Femoral Stem for any reason as a result of an adverse event.

  2. Standard of Care Radiographic assessments [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    Loosening as indicated by radiolucencies > 2mm. In a cemented arthroplasty, this lucency at the bone-cement interface indicates the formation of a fibrous membrane (representing the lucency). Periprosthetic lucencies wider than 2 mm and/or progressive lucencies are signs of abnormality.

  3. Radiographic assessments [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    Evidence of surface wear as indicated by early osteolysis

  4. HOOS JR Questionnaire [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    The HOOS JR. questionnaire consists of 6 questions. These focus on 3 categories: joint pain, stiffness and function in daily living. The HOOS JR. questionnaire, allows patients to rate each activity by indicating the amount of pain or disability they experience while carrying them out. Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 is perfect joint health.

  5. Adverse Events Assessment [ Time Frame: From date of first study visit at Baseline until a 12 year period of safety assessments. ]
    Safety will be evaluated by assessing the frequency and nature of adverse events and serious adverse events to ascertain patient safety and relationship to the implant



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects that have been implanted with the SMF Short Modular Femoral Stem primary stem for primary total hip arthroplasty.
Criteria

Inclusion Criteria:

  • The participant has undergone primary total hip arthroplasty with the SMF short modular femoral stem at the study site and still has the original implant at the time of Ethics Committee approval of the study.
  • The participant is willing and able to participate in follow-up visits at the study site.

Exclusion Criteria:

  • The Subject, in the opinion of the PI, has an emotional or neurological condition that would affect their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
  • Subject is known to be at risk for lost to follow-up or failure to return for scheduled visits.

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): NCT03646513


Contacts
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Contact: Kamla Raniga +61409194229 kamla.raniga@smith-nephew.com

Locations
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Australia, Victoria
Malabar Orthopaedic Clinic Recruiting
Windsor, Victoria, Australia, 3181
Contact: Stephen McMahon    (03) 9510 7766    steve.mcmahon@joint-replacements.com   
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Stephen McMahon Malabar Orthopaedic Institute, Melbourne, Australia.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03646513     History of Changes
Other Study ID Numbers: 18- 4550- 01
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

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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.:
THA