Hip Replacement Clinical Trial
Official title:
Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
NCT number | NCT02230826 |
Other study ID # | 1302-T-HIPLTO-RM |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2044 |
Verified date | March 2023 |
Source | Corin |
Contact | Vanessa Grimaud |
vanessa.grimaud[@]coringroup.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | December 2044 |
Est. primary completion date | December 2034 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Man or woman >18 years - Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study - Subjects who agreed for study participation. Exclusion Criteria: - Subjects with existing tumour and/or particularly high surgical risk- - Subjects with anaesthetic risk class IV or higher - Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.) - Contraindications for arthroplasty with a Corin hip devices as per product IFU |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | |
France | clinique Oxford Cannes | Cannes | |
France | CH Dunkerque | Dunkerque | |
France | Polyclinique Henin Beaumont | Hénin-Beaumont | |
France | CHU de Nice | Nice | |
France | Centre Hospitalier Régionnal d'Orléans - Site La Source | Orléans | |
France | Clinique Arago | Paris | |
France | Hôpital de la Croix Saint-Simon | Paris | |
France | Hopital privé Saint-Martin | Pessac | |
France | Hôpital Provo | Roubaix | |
France | Polyclinique St Georges de Didonne | St Georges de Didonne | |
France | Médipôle Garonne | Toulouse | |
France | Hôpital Jean Bernard | Valenciennes |
Lead Sponsor | Collaborator |
---|---|
Corin |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of long-term outcome after hip arthroplasty with Corin implants. | Implants revision rate at 10-year FU hip arthroplasty | At 10 years | |
Secondary | Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU. | Implants revision rate at 15- and 20-year FU. | at 15- and 20-year | |
Secondary | Evaluation of clinical performance of Corin hip implants | Change of Patient Reported Outcome Measures (PROMs) | starting intraoperatively up to 20-year FU | |
Secondary | Evaluation of Safety of Corin hip implants | Number, severity and causal relationship of procedure or implant-related Adverse Events | starting intraoperatively up to 20-year FU | |
Secondary | Radiological evaluation of positioning and osteointegration of Corin hip implants. | Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation | starting intraoperatively up to 20-year FU | |
Secondary | Evaluation of patient quality of life | Improvement of quality of life via EQ-5D-5L scores. | starting intraoperatively up to 20-year FU | |
Secondary | Evaluation of patient satisfaction following surgery | Improvement of patient's satisfaction | 3 months ; 2.5-year; 6, 11, 15, 20-year visits |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04989998 -
Patient Outcomes Using HIP7 Software as Compared to Conventional THA
|
N/A | |
Completed |
NCT02062437 -
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair
|
N/A | |
Active, not recruiting |
NCT04322916 -
Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
|
||
Recruiting |
NCT04199377 -
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
|
N/A | |
Active, not recruiting |
NCT00664508 -
Mobility Assessment of Patients With Total Hip Arthroplasty
|
N/A | |
Completed |
NCT05627544 -
Blood Transfusion Applications in Hip Replacements
|
||
Enrolling by invitation |
NCT03610789 -
A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPTâ„¢ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted
|
||
Recruiting |
NCT02188199 -
C3 Total Joint Patient Registry
|
N/A | |
Completed |
NCT00398216 -
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
|
Phase 2 | |
Completed |
NCT00328939 -
ARIXTRA Local Study For Registration In China.
|
Phase 3 | |
Completed |
NCT02382835 -
Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
|
N/A | |
Completed |
NCT05343195 -
Balance and Leg Function After Hip Replacement
|
N/A | |
Completed |
NCT04979104 -
Hip Arthroplasty With SL Cementless
|
N/A | |
Recruiting |
NCT05003739 -
Hip Arthroplasty With Logica Mirror Femoral Stem
|
N/A | |
Recruiting |
NCT06178185 -
A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty (PRIORITEES)
|
||
Not yet recruiting |
NCT04886570 -
Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study
|
||
Completed |
NCT02707302 -
Surgical Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty
|
N/A | |
Recruiting |
NCT06161194 -
Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty
|
N/A | |
Completed |
NCT05184725 -
CARINAE for Stress Relief in Perioperative Care
|
N/A | |
Completed |
NCT05710107 -
QL vs PENG for Analgesia After Hip Arthroplasty
|
N/A |