A Prospective Clinical Study On A Total Hip Resurfacing System
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
- Total Harris hip score
- Device revisions or removals
Secondary endpoints:
- Total Harris hip score
- Radiographic changes as evidenced by:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Sint Niklaas, Belgien
- Az Nikolaas Campus Sint Niklaas
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with a preoperative Total Harris Hip Score of < 70
- Conservative treatment has proven unsuccessful
- Primary hip surgery
Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- Osteoarthritis
- Avascular necrosis
- Legg Perthes
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Developmental Dysplasia, which does not prevent stable acetabular reconstruction
- Post traumatic arthritis S. Patients at least 18 years of age
6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form
Exclusion Criteria:
- Patients with a preoperative Total Harris Hip Score of > 70
- Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- Developmental dysplasla, which prevents stable acetabular reconstruction
- Patients with previous Girdlestone procedures
- Patients with above knee amputation of the contralateral and/or ipsilateral leg
- Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
- Active or suspected systemic or localized Infection
- Parkinson's or Alzheimer's Disease
- Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
- Patients less than 18 years of age
- Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
- Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
- Patients with a "fused"hip
- Patients with metal allergy or hypersensitivity
- Participation in a study of any investigational product (drug or device) within the past 12 months
- Prisoners,known drug or alcohol abuser,or mentally incompetent individuals
- Systemic steroids within 6 months
- Patients with a known malignancy
- Patients who are pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: ReCap
ReCap Total Hip Resurfacing System
|
Dette er et hofte resurfacing system.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Harris Hofte Score, Enhedsrevision/Fjernelse, Radiografisk Evaluering
Tidsramme: 2 år efter operationen
|
2 år efter operationen
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Komplikationer
Tidsramme: Når som helst
|
Når som helst
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jo De Schepper, MD, AZ Nikolaas
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EU-8
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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