Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups

NCT00859976 | Completed Results

• 2 other identifiers: BMETEU.CR.EU27UK REC Ref: 08/H0724/24
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthropathy of Hip

Keywords

BoneMaster; Total Hip Replacement; Bone Density; Patients suitable for Total Hip Replacement

Outcome Measures

Primary Outcomes (2)

• Record and Measure Bone Density Using DEXA Scans at 24 Months.

  DEXA scan cohort - DEXA scan was used to measure bone density. Below is the calculated net average bone mineral density (BMD) percentage change from baseline at 2 years.

  2 years.

• Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.

  34 patient cases without duplicated data were the basis for the radiographic analysis that was conducted: Bonemaster group, n = 12; Plasma-Sprayed group, n = 22. The degree of osseous-fixation was determined by grading: 1-2 mm radiolucencies, classed as not fixated; \>2mm radiolucencies, classed as unstable.

  2 years.

Secondary Outcomes (3)

• Secondary Outcomes Are Functional Assessment Using Harris Hip Score

  2 years

• Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score

  2 years.

• Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score

  2 years

Study Arms (2)

Plasma-sprayed shell

ACTIVE COMPARATOR

Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.

Device: Plasma Coated Acetabular Shell

BoneMaster coated shell

EXPERIMENTAL

Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.

Device: BoneMaster coated acetabular shell.

Interventions

BoneMaster coated acetabular shell. DEVICE

Bonemaster coated Exceed Acetabular Shell

Also known as: Bonemaster coated Exceed Acetabular Shell

BoneMaster coated shell

Plasma Coated Acetabular Shell DEVICE

Plasma HA coated Exceed Acetabular Shell

Also known as: Plasma Hydroxyapatite coated Exceed Acetabular Shell

Plasma-sprayed shell

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

William Harvey Hospital

Ashford, Kent, TN24 0LZ, United Kingdom

Location

Results Point of Contact

• Title: Clinical Project Lead
• Organization: Zimmer Biomet

Maggie.Shen@zimmerbiomet.com

Study Officials

• Helmut ZAHN

  William Harvey Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: May 1, 2014
• Last Updated: March 5, 2019
• Results First Posted: February 8, 2019

Record last verified: 2019-02

Locations

GB (1)