Status:
TERMINATED
Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Total Hip Replacement System
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.
Detailed Description
This investigational device study is a non-randomized, non-inferiority, multi-center, historically controlled study. The primary objective will be evaluated at the primary endpoint (24 months) by the ...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older at the time of enrollment,
- Patient is skeletally mature,
- Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study,
- Patient agrees to comply with this protocol, including participating in required follow-up visits at the investigational site and completing study questionnaires, (i.e. patient's reasonable driving distance to assure study follow-up and completion)
- Investigator determines patient is a suitable candidate for primary total hip replacement,
- Body Mass Index (BMI) of \<40,
- Preoperative Harris Hip Score (HHS) \< 70 points as calculated on the Pre-screening Qualification Form and verified by the Sponsor,
- Have a diagnosis of degenerative joint disease of the hip.
Exclusion
- Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side,
- Patients with a previous Girdlestone procedure,
- Patient has a known metal allergy to any component of the investigational device (e.g.cobalt, chromium, titanium or ceramics),
- Patient has had a total knee arthroplasty of either leg,
- Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb (based on the Investigator's discretion),
- Patients with congenital disorder or deformity not adequately addressed by hip replacement or has sufficient anatomic variance or remodeling of the hip joint that may place the patient at risk for mechanical failure or that requires a structural bone graft (based on the Investigator's discretion),
- Patients with severe instability or deformity of the ligaments or surrounding soft tissues that would preclude stability of the implant (based on the Investigator's discretion),
- Patients with Charcot or neuropathic arthropathy, or neuromuscular disease or any other condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion),
- Patient, male or postmenopausal female, with a history of metabolic bone disease, as defined by the following:
- Osteoporosis where the patient is currently taking prescription medications that increase bone-mineral density (e.g. Fosamax, Didronel), or
- Patient was previously diagnosed with a metabolic bone disease (e.g. Paget's disease or osteomalacia), or
- Patient has any other metabolic bone disease to a degree that the investigator determines that a THR would be contraindicated,
- Active malignancy,
- Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)- systemic or at the site of intended surgery,
- Clinical diagnosis of renal insufficiency where renal function is abnormal and incapable of sustaining essential bodily functions. (e.g. as reported by KRONOS lab BUN, Creatinine and estimated glomerular filtration rate (GFR \<15 mL/min/1.73 m2)
- Currently participating in any investigational studies not related to this study's preoperative or postoperative care,
- Patient has a mental illness or belongs to a vulnerable population (e.g., is a prisoner or a severe drug abuser, or is developmentally disabled) such that his or her ability to provide informed consent or comply with follow-up requirements is compromised,
- Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to the required x-rays for the study),
- Other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the investigator, which would make the patient inappropriate for entry into this study.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00820443
Start Date
June 1 2007
End Date
October 1 2013
Last Update
September 30 2015
Active Locations (1)
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1
St. Vincent's Hospital
Los Angeles, California, United States, 90057