Clinical Trials Logo
  1. Home
  2. Hip Arthropathy
  3. NCT06096155

Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem — 2022-09  

Hip Arthropathy Clinical Trial

Official title:
Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

Clinical Trial Summary

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices. The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems. Secondary objectives are to : - study long term patient satisfaction with their hip prosthesis, - confirm the long-term safety of these implants by studying the possible complications observed, - evaluate the performance of these implants using clinical scores.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06096155
Study type Observational
Source Societe dEtude, de Recherche et de Fabrication
Contact Lydie BONNEVAY
Phone 04 72 05 60 10
Email l.bonnevay@serf.fr
Status Recruiting
Phase
Start date June 13, 2023
Completion date August 31, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05556759 - Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Not yet recruiting NCT05015517 - ESP Block vs FIB in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Recruiting NCT04438265 - Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Recruiting NCT04229368 - Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications N/A
Active, not recruiting NCT05142462 - Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Completed NCT06083428 - Erector Spinae vs. PENG Block for Total Hip Arthroplasty Phase 4
Completed NCT05396924 - Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy N/A
Active, not recruiting NCT05524363 - Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty
Recruiting NCT06147401 - Comparison of PENG Associated With LFCN Block Versus FICB for Multimodal Analgesic Management in THA N/A
Completed NCT03977454 - Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty Phase 2
Recruiting NCT05397145 - Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty N/A
Completed NCT03981354 - Nutritional Status and Its Modifications After Hip Replacement
Recruiting NCT06257160 - Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery N/A
Active, not recruiting NCT04995822 - Post Market Clinical Follow-up of EUROSTEM Femoral Stem
Completed NCT04883788 - The Impact of COVID-19 Pandemic on Hip and Knee Replacement
Not yet recruiting NCT06317870 - Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty N/A
Completed NCT03541798 - Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia N/A
Completed NCT04306133 - PENG Block Combined to Wound Infiltration for Hip Replacement N/A