Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (MISDexa)
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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" |
- 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: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
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 |
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.
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| Contact: Stacey Alexander | 901.399.5356 ext 5356 | stacey.alexander@smith-nephew.com |
| Contact: Candi Langmaid | 901.399.5551 ext 5551 | candi.langmaid@smith-nephew.com |
| Australia | |
| Malabar Orthopaedic Clinic | Recruiting |
| Windsor, Australia, 3181 | |
| Contact: Gabrielle Hawdon 61 3 9510 7766 gabrielle@joint-replacements.com | |
| 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: | September 17, 2012 |
| 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 June 18, 2013