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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthropathy of Hip
• Intervention / Treatment: Device: Plasma Coated Acetabular Shell; Device: BoneMaster coated 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.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Ashford, Kent, United Kingdom, TN24 0LZ
      • William Harvey Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Bonemaster coated Exceed Acetabular Shell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcomes Are Functional Assessment Using Harris Hip Score	Modified Harris Hip Score, total score 0-100. A score of <70 is poor, 70-79 is fair, 80-89 is good, 90-100 is excellent.	2 years
Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score	Oxford Hip Score, scored 12-60. The Oxford hip score - this score was based on the original publication where each answer gives a score of 1-5. A score of 1 for each question, represented best outcome/least symptoms. Therefore a total score of 12 was the best overall outcome.	2 years.
Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Hip Score, Each question is scored on a scale of 0 (best health state) to 4 (worst health state); total WOMAC hip score, 0 being the best and 96 being the worst.	2 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Helmut ZAHN, William Harvey Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (ESTIMATE): March 11, 2009

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Bone Density; Total Hip Replacement; BoneMaster; Patients suitable for Total Hip Replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: BMETEU.CR.EU27; UK REC Ref: 08/H0724/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED