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Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (MISDexa)

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ClinicalTrials.gov Identifier: NCT01066936
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

Condition or disease
Osteoarthritis, Hip

Detailed Description:
The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
Study Start Date : August 2009
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. DEXA analysis, Hip Osteoarthritis Outcome Score (HOOS), Radiographic assessment, Surgical and device related Adverse Events. [ Time Frame: Preoperative, Operative/Discharge, 3 months, 1 year, 2 years, 3 years, and 5 years. Each patient will receive standard radiographic evaluation at discharge and DEXA at pre-op to be used for baseline analysis. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The purpose of this investigation is to assess the bone growth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a total hip replacement.
Criteria

Inclusion Criteria:

  • Patient has hip disease that requires a total hip arthroplasty.
  • Patient is willing to consent to participate in the study.
  • Patient plans to be available for the study duration.
  • 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 known to have insufficient bone stock.
  • Patient has had major non-arthroscopic surgery to the study hip.
  • Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
  • Patient has a known sensitivity to materials in the device.

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): NCT01066936


Locations
Australia
Malabar Orthopaedic Clinic
Windsor, Australia, 3181
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Steve McMahon, MD Malabar Orthopaedic Clinic

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01066936     History of Changes
Other Study ID Numbers: 2090SMFH131
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases