Clinical trial NCT00820443: Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial
Official title: Ceramic on Metal Total Hip Replacement System IDE: A Non-Randomized, Multi-center, Historically Controlled Safety and Efficacy Study (Protocol Number:06-LJH-002)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Total Hip Replacement System
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 primary efficacy and safety measures that define patient success. The proportion of patient success will determine whether the primary objective has been met (study success).

The investigational device will be compared to a historical control comprised of patients from the TRANSCEND® Ceramic on Ceramic IDE study. This comparison will be made using all primary and secondary measures. However, only primary measures will be used to determine study success.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years of age or older at the time of enrollment,
2. Patient is skeletally mature,
3. Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study,
4. 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)
5. Investigator determines patient is a suitable candidate for primary total hip replacement,
6. Body Mass Index (BMI) of \<40,
7. Preoperative Harris Hip Score (HHS) \< 70 points as calculated on the Pre-screening Qualification Form and verified by the Sponsor,
8. Have a diagnosis of degenerative joint disease of the hip.

Exclusion Criteria:

1. Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side,
2. Patients with a previous Girdlestone procedure,
3. Patient has a known metal allergy to any component of the investigational device (e.g.cobalt, chromium, titanium or ceramics),
4. Patient has had a total knee arthroplasty of either leg,
5. Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb (based on the Investigator's discretion),
6. 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),
7. 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),
8. 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),
9. 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,
10. Active malignancy,
11. Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)- systemic or at the site of intended surgery,
12. 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)
13. Currently participating in any investigational studies not related to this study's preoperative or postoperative care,
14. 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,
15. Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to the required x-rays for the study),
16. 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.

Primary outcomes:
measure: Primary Endpoint/Measures: Success at 24 Months
timeFrame: 24 Month
Secondary outcomes:
measure: The Secondary Measures of the UCLA Functional Assessments
timeFrame: 24 months
measure: WOMAC Raw Total Score
timeFrame: 24 months
measure: Metal Ion Analysis (Unilateral Only):Serum Cobalt
timeFrame: 24 months
measure: Metal Ion Analysis; Unilateral Only; Serum Chromium
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: St. Vincent's Hospital
state: California
Study officials:
References:
citation: National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.