Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Wael Barsoum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01183260
First received: August 13, 2010
Last updated: September 11, 2013
Last verified: September 2013

August 13, 2010
September 11, 2013
August 2010
December 2015   (final data collection date for primary outcome measure)
Periprosthetic Bone Mineral Density (BMD) of Hip [ Time Frame: 2 years postoperative; measured at 4 weeks (baseline), 3 months, 6 months, 1year, 2 year postoperative ] [ Designated as safety issue: No ]
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques.
Periprosthetic bone mineral density (BMD) of Hip [ Time Frame: 2 years post operative; measured at 7-14 d (baseline), 3 mo, 6 mo, 1yr, 2 yr ] [ Designated as safety issue: No ]
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques.
Complete list of historical versions of study NCT01183260 on ClinicalTrials.gov Archive Site
Functional and General Health Outcome Assessments [ Time Frame: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative ] [ Designated as safety issue: No ]
Analyze and compare functional and general health outcomes of these patients, based on HOOS and SF-12v2.
Clinical Outcomes of Patients [ Time Frame: 2 years post operative; measured preoperatively, 3 mo, 6 mo, 1 yr, 2 yr ] [ Designated as safety issue: No ]
Analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
Not Provided
Not Provided
 
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)

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 address the limitations of other implant materials, with the potential to improve implant fixation.

Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA.

Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up.

Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components.

The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.

none provided.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Revision, Joint
  • Device: Zimmer Trabecular Metal Revision Cup
    Revision of the acetabular cup
  • Device: Zimmer Modular Cup
    Revision of the acetabular cup
  • Experimental: Zimmer Trabecular Metal Acetabular Cup
    Intervention: Device: Zimmer Trabecular Metal Revision Cup
  • Active Comparator: Zimmer Modular Cup
    Intervention: Device: Zimmer Modular Cup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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).
Both
18 Years to 85 Years
No
Contact: Alison K Klika, MS (216) 444-4954 klikaa@ccf.org
United States
 
NCT01183260
ZIMM1007WB, 09-859
Yes
Wael Barsoum, The Cleveland Clinic
The Cleveland Clinic
Zimmer, Inc.
Principal Investigator: Wael K Barsoum, MD The Cleveland Clinic
The Cleveland Clinic
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP