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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01066936
First received: February 9, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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
Osteoarthritis, Hip

Study Type: Observational
Study Design: 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"

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066936

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

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01066936     History of Changes
Other Study ID Numbers: US-CR-131
Study First Received: February 9, 2010
Last Updated: March 5, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 22, 2014