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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Arthropathy of Hip

Intervention / Treatment
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* Device: BoneMaster coated acetabular shell.
* Device: Plasma Coated Acetabular Shell


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plasma-sprayed shell<br>Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup. | Device: Plasma Coated Acetabular Shell<br>* Plasma HA coated Exceed Acetabular Shell<br>* Other names: Plasma Hydroxyapatite coated Exceed Acetabular Shell;|
| Experimental: BoneMaster coated shell<br>Exceed ABT BoneMaster hydroxyapatite coated acetabular cup. | Device: BoneMaster coated acetabular shell.<br>* Bonemaster coated Exceed Acetabular Shell<br>* Other names: Bonemaster coated Exceed Acetabular Shell;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BoneMaster, Total Hip Replacement, Bone Density, Patients suitable for Total Hip Replacement