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
  Purpose

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.


Condition Intervention Phase
Revision, Joint
Device: Zimmer Trabecular Metal Revision Cup
Device: Zimmer Modular Cup
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zimmer Trabecular Metal Acetabular Cup Device: Zimmer Trabecular Metal Revision Cup
Revision of the acetabular cup
Active Comparator: Zimmer Modular Cup Device: Zimmer Modular Cup
Revision of the acetabular cup

Detailed Description:

none provided.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183260

Contacts
Contact: Alison K Klika, MS (216) 444-4954 klikaa@ccf.org

Locations
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison K Klika, MS    216-444-4954    klikaa@ccf.org   
Principal Investigator: Wael K Barsoum, MD         
Sub-Investigator: Viktor E Krebs, MD         
Sub-Investigator: Robert Molloy, MD         
Sub-Investigator: Trevor G Murray, MD         
Sub-Investigator: Carlos A Higuera, MD         
Sub-Investigator: Michael R Bloomfield, MD         
Sponsors and Collaborators
The Cleveland Clinic
Zimmer, Inc.
Investigators
Principal Investigator: Wael K Barsoum, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Wael Barsoum, MD, Chairman of Surgical Operations, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01183260     History of Changes
Other Study ID Numbers: ZIMM1007WB, 09-859
Study First Received: August 13, 2010
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
revision total hip arthroplasty
bone mineral density
trabecular metal
DEXA

ClinicalTrials.gov processed this record on August 19, 2014