Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (MISDexa)
This study is currently recruiting participants.
Verified September 2012 by Smith & Nephew, Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
First received: February 9, 2010
Last updated: September 17, 2012
Last verified: September 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
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:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066936
Smith & Nephew, Inc.
||Steve McMahon, MD
||Malabar Orthopaedic Clinic
No publications provided
||Smith & Nephew, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 9, 2010
||September 17, 2012
||Australia: Human Research Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013