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

Osteoarthritis Clinical Trial

Official title:

Multicentric, Open Label With Retrospective Inclusion and 5 Years Prospective Follow-up of Acetabular Prothetic Implant "Polymax"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826187
• Other study ID #: RC31/15/7859
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2022

Study information

• Verified date: June 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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
• 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
• Patient Satisfaction
Patient satisfaction evaluated by Womac reduced Score
• Efficacity
Efficacity as evaluated by Harris HIP score
• Radiographic evaluation
Bone reaction visible in radiography

Locations

Country	Name	City	State
France	Saint Grégoire Hospital	Saint Grégoire
France	Purpan Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Innocuity of POLYMAX acetabular implant as assessed by data collected on early complications		60 months
Primary	Innocuity of POLYMAX acetabular implant as assessed by data collected on late-stage complications		60 months
Secondary	Efficacity of POLYMAX acetabular implant as assessed by Harris clinical score		60 months
Secondary	Patient satisfaction as assessed by Womac reduced score		60 months
Secondary	Evaluation of implant good holding as assessed by apparition of radiolucent lines in radiography		60 months