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

NCT02826187 | Completed

• 1 other identifier: RC31/15/7859
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 2

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

Keywords

Acetabular implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

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; Other: Late stage complications data; Other: Patient Satisfaction; Other: Efficacity; Other: Radiographic evaluation

Interventions

Early complications data 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

Patients with acetabular implant

Late stage complications data 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

Patients with acetabular implant

Patient Satisfaction OTHER

Patient satisfaction evaluated by Womac reduced Score

Patients with acetabular implant

Efficacity OTHER

Efficacity as evaluated by Harris HIP score

Patients with acetabular implant

Radiographic evaluation OTHER

Bone reaction visible in radiography

Patients with acetabular implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with osteoarthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

Saint Grégoire Hospital

Saint-Grégoire, 56816, France

Location

Purpan Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Philippe CHIRON, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2014
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

FR (2)