Full Text View
Tabular View
No Study Results Posted
Related Studies
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups
This study is currently recruiting participants.
Verified December 2011 by Biomet, Inc.

First Received on March 6, 2009.   Last Updated on December 13, 2011   History of Changes
Sponsor: Biomet U.K. Ltd.
Information provided by (Responsible Party): Biomet, Inc. ( Biomet U.K. Ltd. )
ClinicalTrials.gov Identifier: NCT00859976
  Purpose

The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements.

The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x−ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X−ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.


Condition Intervention
Arthropathy of Hip
Device: BoneMaster coated acetabular shell.
Device: Plasma Coated Acetabular Shell

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • The primary outcome of the study is to record and measure bone density and growth using Xray and DEXA scans between the two groups. [ Time Frame: Pre-operatively, 6 months, 1 year, 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes are functional assessment using Harris Hip Score and Clinical Assessment using Oxford Hip Score and Womac Score. [ Time Frame: Pre-operatively, 6 months, 1 year, 2 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2009
Estimated Study Completion Date: August 2024
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plasma-sprayed shell
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Device: Plasma Coated Acetabular Shell
Plasma HA coated Exceed Acetabular Shell
Other Name: Plasma Hydroxyapatite coated Exceed Acetabular Shell
Experimental: BoneMaster coated shell
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
Device: BoneMaster coated acetabular shell.
Bonemaster coated Exceed Acetabular Shell
Other Name: Bonemaster coated Exceed Acetabular Shell

Detailed Description:

The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients will be recruited to the study and each patient will be randomised into either of the groups allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2 years after the surgery. All patients will have radiographic assessments at these follow-up intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of the two groups.

The BoneMaster coating has been extensively tested in cell and animal studies and has been evaluated in one previous clinical study and showed favorable results. Further investigation is required to ensure the new coating may enhance bony growth allowing better fixation of the hips in the early period after the operation and also over a longer period of time. The growth needs to be measured using a more sensitive scan than radiographic assessment alone, called DEXA which was also used in the previous study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients suitable for THR surgery with a diagnosis of Osteoarthritis
  • Patients aged 40 -85 years old.
  • Patients with limited co-morbidity - ASA I - III (low risk for surgery)
  • Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria

  • Rheumatoid arthritis
  • Patients requiring supplemental screw fixation
  • Previous hip surgery to the affected hip
  • Patients with significant co-morbidity - ASA IV - V (high risk for surgery)
  • Dementia
  • Neurological conditions affecting everyday functional ability and hip movement
  • The patient is unable to give informed consent
  • Patients who have suffered from cancer
  • The patient is currently part of another research study
  • Patients who need to take Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the first 6 weeks after surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859976

Contacts
Contact: Helmut Zahn, FRCS +441233 616085 HELMUT.ZAHN@ekht.nhs.uk

Locations
Belgium
CHU Saint Pierre Recruiting
Bruxelles, Belgium
Contact: Philippe DELINCE, Pr            
Principal Investigator: Philippe DELINCE, Pr            
Sub-Investigator: Dior GHAFIL, Dr            
United Kingdom
William Harvey Hospital Recruiting
Ashford, Kent, United Kingdom, TN24 0LZ
Principal Investigator: Helmut Zahn, FRCS            
Sponsors and Collaborators
Biomet U.K. Ltd.
Investigators
Principal Investigator: Helmut ZAHN William Harvey Hospital
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet U.K. Ltd. )
ClinicalTrials.gov Identifier: NCT00859976     History of Changes
Other Study ID Numbers: EU27, UK REC Ref: 08/H0724/24
Study First Received: March 6, 2009
Last Updated: December 13, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Biomet, Inc.:
BoneMaster
Total Hip Replacement
Bone Density
Patients suitable for Total Hip Replacement

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012