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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183260
First Posted: August 17, 2010
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Wael Barsoum, The Cleveland Clinic
  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
Revision, Joint Device: Trabecular Metal Revision Cup Device: Trabecular Metal Modular Cup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Wael Barsoum, The Cleveland Clinic:

Primary Outcome Measures:
  • Periprosthetic Bone Mineral Density (BMD) of Hip [ Time Frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative ]
    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. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.


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 ]

    Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems:

    • SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health.
    • SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health.
    • HOOS Pain assesses pain in the hip
    • HOOS Symptoms assesses symptoms such as stiffness in the hip
    • HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.)
    • HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.)
    • HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life


Enrollment: 25
Study Start Date: August 2010
Study Completion Date: January 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trabecular Metal Revision Cup
Patients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner.
Device: Trabecular Metal Revision Cup
Revision of the acetabular cup
Active Comparator: Trabecular Metal Modular Cup
Patients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner.
Device: Trabecular Metal Modular Cup
Revision of the acetabular cup

Detailed Description:
none provided.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183260


Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Zimmer Biomet
Investigators
Principal Investigator: Wael K Barsoum, MD The Cleveland Clinic
  More Information

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 ( Other Identifier: CCF IRB )
First Submitted: August 13, 2010
First Posted: August 17, 2010
Results First Submitted: September 11, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: October 2017

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