Phase
Condition
Osteoarthritis
Musculoskeletal Diseases
Osteomyelitis
Treatment
Avenir Complete Femoral Stem
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- Failed previous hip surgery including
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study;
Exclusion
Exclusion Criteria:
- Acute, chronic, local, or systemic infections;
- Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- Lack of bony structures proximal or distal to the joint, so that good Inclusioncriteria
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- Failed previous hip surgery including
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study; Exclusion criteria
- Acute, chronic, local, or systemic infections;
- Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- Lack of bony structures proximal or distal to the joint, so that good anchorage of theimplant is unlikely or impossible;
- Total or partial absence of the muscular or ligamentous apparatus;
- Any concomitant diseases that can jeopardize the functioning and the success of theimplant;
- Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel,etc.);
- Local bone tumors and/or cysts;
- Pregnancy;
- Skeletal immaturity.
- Patients unwilling or unable to give consent, or to comply with the follow-up program;
- Patients who have any condition that would - in the judgement of the Investigator -place him/her at undue risk or
- interfere with the study;
- Any vulnerable subject:
- a prisoner
- mentally incompetent or unable to understand what participation in the studyentails
- a known alcohol or drug abuser
- anticipated to be non-compliant
- Patients with plans to relocate during the study follow-up period;
- Individuals whose willingness to volunteer in a clinical investigation could be undulyinfluenced by the expectation, whether justified or not, of benefits associated withparticipation or of retaliatory response from senior members of a hierarchy in case ofrefusal to participate;
Study Design
Study Description
Connect with a study center
Copenhagen University Hospital, Hvidovre
Copenhagen, DK-2650
DenmarkSite Not Available
Nissan Tamagawa Hospital
Setagaya-Ku, Tokyo 410-0302
JapanSite Not Available
Okayama City Hospital
Okayama, 700-0962
JapanSite Not Available
Ikazia Ziekenhuis
Rotterdam, Zuid-Holland 3083 AN
NetherlandsSite Not Available
Sykehuset Innlandet HF
Tynset, 2500
NorwayActive - Recruiting
Sahlgrenska University Hospital - Molndal
Molndal, 43180
SwedenActive - Recruiting
Mississippi Sports Medicine and Orthopaedic Center PLLC
Jackson, Mississippi 39202
United StatesSite Not Available
Heartland Regional Medical Center d.b.a. Mosaic Life Care
Saint Joseph, Missouri 64506
United StatesSite Not Available
Orthopedic & Fracture Clinic, PC
Portland, Oregon 97225
United StatesSite Not Available
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