CoMplete™ Acetabular Hip System

Osteoarthritis Clinical Trial

Official title:

Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543230
• Other study ID #: 09014
• Status: Terminated
• Phase: N/A
• First received: February 27, 2012
• Last updated: April 7, 2014
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

Description:

This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 1. If the subject:

1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or

2. Qualifies based on the approved labeling for the device; and

• 2. Is willing and able to provide informed patient consent for participation in the PAS study; and

• 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and

• 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

• consented to participate,

• authorized release of Personal Health Information (PHI),

• met all eligibility criteria through the operative stage, and

• received the implant as noted in this protocol.

Exclusion Criteria:

• Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Post-traumatic Arthritis

Intervention

Device:
• Total hip replacement
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Locations

Country	Name	City	State
United States	Hip and Knee Arkansas Foundation	Little Rock	Arkansas
United States	Orthopaedic Specialty Institute	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).	10 years	Yes
Secondary	Metal Ion Levels	A subset of subjects will be measured for serum cobalt, serum chromium, erythrocytes cobalt, erythrocytes chromium, whole blood cobalt, and whole blood chromium levels. These subjects will also be measured for BUN and creatine levels.	5 years, 8 years, and 10 years postoperatively	Yes