Arthropathy of Hip
Conditions
Keywords
BoneMaster, Total Hip Replacement, Bone Density, Patients suitable for Total Hip Replacement
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.
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.
Interventions
DEVICEBoneMaster coated acetabular shell.
Bonemaster coated Exceed Acetabular Shell
DEVICEPlasma Coated Acetabular Shell
Plasma HA coated Exceed Acetabular Shell
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Record and Measure Bone Density Using DEXA Scans at 24 Months. | 2 years. | 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. |
| Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. | 2 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes Are Functional Assessment Using Harris Hip Score | 2 years | 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. |
| Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score | 2 years. | 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. |
| Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score | 2 years | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plasma-sprayed Shell Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell | 82 |
| BoneMaster Coated Shell Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell | 85 |
| Total | 167 |
Baseline characteristics
| Characteristic | Plasma-sprayed Shell | BoneMaster Coated Shell | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 9 | 68.55 years STANDARD_DEVIATION 8.52 |
| Sex: Female, Male Female | 43 Participants | 51 Participants | 94 Participants |
| Sex: Female, Male Male | 39 Participants | 34 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 82 | 10 / 85 |
| serious Total, serious adverse events | 1 / 82 | 2 / 85 |
Outcome results
Primary
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.
Time frame: 2 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma-sprayed Shell | Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. | 1-2 mm radiolucency in Zone B1 | 3 Participants |
| Plasma-sprayed Shell | Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. | >2 mm radiolucency in zone B2 | 1 Participants |
| BoneMaster Coated Shell | Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. | 1-2 mm radiolucency in Zone B1 | 0 Participants |
| BoneMaster Coated Shell | Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum. | >2 mm radiolucency in zone B2 | 0 Participants |
Primary
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.
Time frame: 2 years.
Population: DEXA scan cohort: Bonemaster group, n = 7; Plasma-Sprayed group, n = 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasma-sprayed Shell | Record and Measure Bone Density Using DEXA Scans at 24 Months. | -11.0 Net average BMD %change from baseline | Standard Deviation 4 |
| BoneMaster Coated Shell | Record and Measure Bone Density Using DEXA Scans at 24 Months. | 5.7 Net average BMD %change from baseline | Standard Deviation 57.3 |
p-value: 0.457Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 2 years.
Population: 2 years post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasma-sprayed Shell | Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score | 19.2 Units on a scale | Standard Deviation 8 |
| BoneMaster Coated Shell | Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score | 19.8 Units on a scale | Standard Deviation 9.2 |
Secondary
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.
Time frame: 2 years
Population: 2 years post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasma-sprayed Shell | Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score | 14.2 Units on a Scale | Standard Deviation 16.5 |
| BoneMaster Coated Shell | Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score | 12.1 Units on a Scale | Standard Deviation 17.4 |
Secondary
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.
Time frame: 2 years
Population: 2 years post-op
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Plasma-sprayed Shell | Secondary Outcomes Are Functional Assessment Using Harris Hip Score | 83.92 Units on a scale | Standard Deviation 15.82 |
| BoneMaster Coated Shell | Secondary Outcomes Are Functional Assessment Using Harris Hip Score | 81.83 Units on a scale | Standard Deviation 20.79 |