Status:
COMPLETED
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Revision, Joint
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to a...
Detailed Description
none provided.
Eligibility Criteria
Inclusion
- Age: 18 - 85 years
- Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
- Stable Health: At the time of surgery based on physical examination and medical history.
- Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
- Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Exclusion
- Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
- Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
- Patients with history of radiation therapy.
- Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
- Patients with known diagnosis of renal disease.
- Patients with known diagnosis of osteoporosis.
- Patients with history of steroid use in the hip joint region.
- Patients that have had a previous lumbar fusion.
- Patients whose surgical reconstruction required a pelvic cage or plate.
- Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
- Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (\~2 years postoperative).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01183260
Start Date
August 1 2010
End Date
January 1 2017
Last Update
November 7 2017
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195