Restoration® Modular Revision Hip System Post Market Study

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Clinical Trial Description

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT00962013
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Completed
Phase	N/A
Start date	January 2004
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05666479` - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Recruiting	`NCT03746925` - Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches	N/A
Completed	`NCT03008967` - A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark	N/A
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT00980616` - Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)	Phase 2
Completed	`NCT04542174` - PMCF 8 Year Results TRJ®
Not yet recruiting	`NCT04019925` - Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis	N/A
Recruiting	`NCT06102811` - Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty	N/A
Recruiting	`NCT03570944` - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
Recruiting	`NCT02938962` - Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)	Phase 4
Completed	`NCT03076827` - Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol	N/A
Recruiting	`NCT02385383` - An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study	N/A
Completed	`NCT01444586` - Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)	N/A
Terminated	`NCT02525627` - A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads	N/A
Completed	`NCT00808483` - Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty	N/A
Terminated	`NCT00958347` - Omnifit Hydroxylapatite (HA) Hip Outcomes Study	N/A
Completed	`NCT01422304` - Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)	Phase 3
Completed	`NCT04332055` - RCT Measuring the Effect of the ERVIN Software	N/A
Completed	`NCT01257568` - Rejuvenate Modular Outcomes Study	N/A
Recruiting	`NCT01031732` - Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty	N/A