N/A
N=167
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups
Arthropathy of Hip
Bottom Line
View on ClinicalTrials.gov: NCT00859976 ↗Enrolled (actual)
167
Serious AEs
1.8%
Results posted
Feb 2019
Primary outcome: Primary: Record and Measure Bone Density Using DEXA Scans at 24 Months. — -11.0; 5.7 Net average BMD %change from baseline — p=0.4570
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BoneMaster coated acetabular shell. (Device); Plasma Coated Acetabular Shell (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Record and Measure Bone Density Using DEXA Scans at 24 Months. |
-11.0; 5.7 | 0.4570 |
| PRIMARY Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. |
3; 0; 1; 0 | — |
| SECONDARY Secondary Outcomes Are Functional Assessment Using Harris Hip Score |
83.92; 81.83 | — |
| SECONDARY Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score |
19.2; 19.8 | — |
| SECONDARY Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score |
14.2; 12.1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00859976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.