Clinical trial NCT02826187: Multicentric, Open Label With Retrospective Inclusion and Follow-up of Acetabular Prothetic Implant "Polymax"
Official title: Multicentric, Open Label With Retrospective Inclusion and 5 Years Prospective Follow-up of Acetabular Prothetic Implant "Polymax"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Acetabular implant
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with osteoarthritis

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"


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

Primary outcomes:
measure: Innocuity of POLYMAX acetabular implant as assessed by data collected on early complications
timeFrame: 60 months
measure: Innocuity of POLYMAX acetabular implant as assessed by data collected on late-stage complications
timeFrame: 60 months
Secondary outcomes:
measure: Efficacity of POLYMAX acetabular implant as assessed by Harris clinical score
timeFrame: 60 months
measure: Patient satisfaction as assessed by Womac reduced score
timeFrame: 60 months
measure: Evaluation of implant good holding as assessed by apparition of radiolucent lines in radiography
timeFrame: 60 months
Other outcomes:
Locations:
city: Saint Grégoire
country: France
facility: Saint Grégoire Hospital
city: Toulouse
country: France
facility: Purpan Hospital
Study officials:
affiliation: University Hospital of Toulouse
name: Philippe CHIRON, MD
role: PRINCIPAL_INVESTIGATOR
References: