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NCT Number: NCT02826187

Multicentric, Open Label With Retrospective Inclusion and 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"

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Grégoire Hospital, Saint-Grégoire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Patient Satisfaction

Other

Patient satisfaction evaluated by Womac reduced Score

Efficacity

Other

Efficacity as evaluated by Harris HIP score

Radiographic evaluation

Other

Bone reaction visible in radiography

Primary outcomes

  1. Innocuity of POLYMAX acetabular implant as assessed by data collected on early complications

    Time frame: 60 months

  2. Innocuity of POLYMAX acetabular implant as assessed by data collected on late-stage complications

    Time frame: 60 months

Secondary outcomes

  1. Efficacity of POLYMAX acetabular implant as assessed by Harris clinical score

    Time frame: 60 months

  2. Patient satisfaction as assessed by Womac reduced score

    Time frame: 60 months

  3. Evaluation of implant good holding as assessed by apparition of radiolucent lines in radiography

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2016
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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