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
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, see Learn About Clinical Studies.

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 September 29, 2014