Overview

This trial is active, not recruiting.

Condition osteoarthritis, hip
Sponsor Smith & Nephew, Inc.
Start date August 2009
End date August 2016
Trial size 20 participants
Trial identifier NCT01066936, US-CR-131

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
Principal investigator Steve McMahon, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..