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Multicentric, Open Label With Retrospective Inclusion and Follow-up of Acetabular Prothetic Implant "Polymax"

NCT02826187 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 181

Last updated 2024-06-12

No results posted yet for this study

Summary

Total replacement of hip joint is one of the most important medical innovations of the twentieth century. More than 100,000 hip replacements are being laid each year in France.

Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects of continuous improvement.

Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons for joint replacement of the defective hip.

The anchor and friction torque are both essential to the survival of hip implants. Therefore acetabular implants without cement with ceramic insert or polyethylene in a metalback or full polyethylene coated with titanium grains without metalback are proposed, but they have their own complications (Squeaking, fractures, recovery difficulties, difficult radiographic analysis, high cost for ceramics, primary stability defects, instability of the instrument set, Titanium residues in absence of metalback. An alternative to these implants may be an acetabular component without cement with polyethylene insert with an end metalback to increase both polyethylene thickness and size of the head in order to expect a low complication rate with important longevity for a lower cost.

This study was conducted to ensure the safety and effectiveness of the acetabular implant "POLYMAX"

Conditions

Interventions

OTHER

Early complications data

Early complications of interest are : * New arthroplasty for any reason * Related to the implant : * Wrong position of the implant * Early displacement of the implant * Related to the intervention : * Hematoma * Dislocation (or not causing the resumption of joint replacement) * Deep vein thrombosis * Pulmonary embolism * Acute Infection

OTHER

Late stage complications data

Late complications taken into account are: * New arthroplasty for any reason * Aseptic loosening * Delayed hypersensitivity reaction type IV * Solid Tumors * Recurrent dislocation (causing or not the resumption of joint replacement) * Allergic reactions of any kind * Chronic infection

OTHER

Patient Satisfaction

Patient satisfaction evaluated by Womac reduced Score

OTHER

Efficacity

Efficacity as evaluated by Harris HIP score

OTHER

Radiographic evaluation

Bone reaction visible in radiography

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Philippe CHIRON, MD · University Hospital of Toulouse

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2021-07-31
Completion
2022-07-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826187 on ClinicalTrials.gov