Total Hip Arthroplasty Clinical Trial
Official title:
Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty. The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty evaluated through the Kaplan Meier curve. The secondary objectives of the study are: - To assess the function of the operated hip - Evaluate the safety of the implant - Evaluate the stability of the prosthetic components Secondary endpoints were: - Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility and stability and a deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria. - Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component. - Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs. The arithmetic summation of these "risk factors" will lead to a final "score", defining the adaptation of the prosthesis to the bone sleeve at the time the images are taken, and which may naturally vary with time, either positively, if the fixation, which was precarious at the time, stabilizes (secondary osteoinduction by Hydroxyapatite of initial fibrosis zones, for example), or negatively in the presence of an evolving destabilization (there is obviously no negative score). The approach is similar for the femur and for the acetabulum. ❖ Collection of intraoperative and postoperative complications. Complications, such as infection, loosening, deep vein thrombosis (DVT), fracture, as well as other unexpected complications, will be evaluated. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02818894 -
Spinal Anesthesia in Total Hip Arthroplasty
|
Phase 4 | |
| Completed |
NCT02242201 -
Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular
|
Phase 4 | |
| Completed |
NCT02414542 -
Minima Clinical Study
|
||
| Completed |
NCT01817010 -
Strength and Function Following Total Hip Arthroplasty
|
N/A | |
| Completed |
NCT01443975 -
Clinical Evaluation on the Use of the X-pander Device
|
N/A | |
| Recruiting |
NCT05530551 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
|
N/A | |
| Recruiting |
NCT05530174 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture
|
N/A | |
| Recruiting |
NCT06141928 -
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
|
N/A | |
| Recruiting |
NCT05054192 -
Reliability and Validity of Modified Four Square Step Test
|
||
| Recruiting |
NCT04492462 -
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
|
N/A | |
| Withdrawn |
NCT02926651 -
Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty
|
Phase 4 | |
| Completed |
NCT02308813 -
Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip
|
N/A | |
| Recruiting |
NCT02032017 -
Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.
|
N/A | |
| Recruiting |
NCT01312077 -
The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement
|
Phase 4 | |
| Withdrawn |
NCT01380665 -
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
|
Phase 4 | |
| Recruiting |
NCT05893563 -
Corail Stability at 5-Years Post-Total Hip Arthroplasty
|
||
| Recruiting |
NCT06088069 -
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
|
N/A | |
| Active, not recruiting |
NCT03210844 -
The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty
|
N/A | |
| Recruiting |
NCT04801680 -
Mpact 3D Metal Cup PMS
|
||
| Terminated |
NCT02006251 -
Real-Time Instrument for Acetabular Shell Positioning
|