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

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

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"

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Early complications data; Other: Late stage complications data; Other: Patient Satisfaction; Other: Efficacity; Other: Radiographic evaluation

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• France
  • Saint Grégoire, France, 56816
    • Saint Grégoire Hospital
  • Toulouse, France, 31059
    • Purpan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with osteoarthritis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Early complications data; Early complications of interest are : New arthroplasty for any reason; Related to the implant :Wrong position of the implantEarly displacement of the implant; Related to the intervention :HematomaDislocation (or not causing the resumption of joint replacement)Deep vein thrombosisPulmonary embolismAcute 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Innocuity of POLYMAX acetabular implant as assessed by data collected on early complications	60 months
Innocuity of POLYMAX acetabular implant as assessed by data collected on late-stage complications	60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacity of POLYMAX acetabular implant as assessed by Harris clinical score	60 months
Patient satisfaction as assessed by Womac reduced score	60 months
Evaluation of implant good holding as assessed by apparition of radiolucent lines in radiography	60 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Philippe CHIRON, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimated): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Acetabular implant
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: RC31/15/7859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED