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

NCT ID: NCT02826187

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2022-07-31

Brief 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

Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with acetabular implant

Data to be collected are :

• Early complications data related to implant or procedure of implantation
• Late stage complications data
• Efficacity of treatment with HIP score
• Patient satisfaction
• Radiographic evaluation during standard follow-up

Early complications data

Intervention Type: OTHER

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

Late stage complications data

Intervention Type: OTHER

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

Patient Satisfaction

Intervention Type: OTHER

Patient satisfaction evaluated by Womac reduced Score

Efficacity

Intervention Type: OTHER

Efficacity as evaluated by Harris HIP score

Radiographic evaluation

Intervention Type: OTHER

Bone reaction visible in radiography

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Patient Satisfaction

Patient satisfaction evaluated by Womac reduced Score

Intervention Type: OTHER

Efficacity

Efficacity as evaluated by Harris HIP score

Intervention Type: OTHER

Radiographic evaluation

Bone reaction visible in radiography

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient suffering from hip disease: primary or secondary hip osteoarthritis or osteonecrosis.
• Patient having been implanted with a POLYMAX implant;
• Patient having agreed to participate in a follow-up 5 years;
• Patient who have accepted the use of their data in the context of this study.
• Patient having pre-operative and post-operative data

Exclusion Criteria

• Pre or post-operative Partial data
• Patients not available for follow up at 2 and 5 years ..
• Metabolic disease or autoimmune witch may interfere with bone growth not allowing the indication of a prosthesis without cement,
• Mental disorder or disease of proven behavior.
• Severe osteoporosis,
• Direct or indirect bone irradiation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe CHIRON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

Saint Grégoire Hospital

Saint-Grégoire, , France

Purpan Hospital

Toulouse, , France

Countries

France

Other Identifiers

RC31/15/7859

Identifier Type: -

Identifier Source: org_study_id