Trial Outcomes & Findings for Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups (NCT NCT00859976)
NCT ID: NCT00859976
Last Updated: 2019-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
2 years.
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Plasma-sprayed Shell
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
85
|
|
Overall Study
COMPLETED
|
66
|
67
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups
Baseline characteristics by cohort
| Measure |
Plasma-sprayed Shell
n=82 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=85 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7 • n=99 Participants
|
70 years
STANDARD_DEVIATION 9 • n=107 Participants
|
68.55 years
STANDARD_DEVIATION 8.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 years.Population: DEXA scan cohort: Bonemaster group, n = 7; Plasma-Sprayed group, n = 7
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.
Outcome measures
| Measure |
Plasma-sprayed Shell
n=7 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=7 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Record and Measure Bone Density Using DEXA Scans at 24 Months.
|
-11.0 Net average BMD %change from baseline
Standard Deviation 4.0
|
5.7 Net average BMD %change from baseline
Standard Deviation 57.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Plasma-sprayed Shell
n=22 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=12 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.
1-2 mm radiolucency in Zone B1
|
3 Participants
|
0 Participants
|
|
Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.
>2 mm radiolucency in zone B2
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 2 years post-op
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.
Outcome measures
| Measure |
Plasma-sprayed Shell
n=59 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=60 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Secondary Outcomes Are Functional Assessment Using Harris Hip Score
|
83.92 Units on a scale
Standard Deviation 15.82
|
81.83 Units on a scale
Standard Deviation 20.79
|
SECONDARY outcome
Timeframe: 2 years.Population: 2 years post-op
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.
Outcome measures
| Measure |
Plasma-sprayed Shell
n=59 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=61 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score
|
19.2 Units on a scale
Standard Deviation 8
|
19.8 Units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 2 years post-op
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.
Outcome measures
| Measure |
Plasma-sprayed Shell
n=41 Participants
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=47 Participants
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score
|
14.2 Units on a Scale
Standard Deviation 16.5
|
12.1 Units on a Scale
Standard Deviation 17.4
|
Adverse Events
Plasma-sprayed Shell
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
BoneMaster Coated Shell
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plasma-sprayed Shell
n=82 participants at risk
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=85 participants at risk
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/82
|
2.4%
2/85
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.2%
1/82
|
0.00%
0/85
|
Other adverse events
| Measure |
Plasma-sprayed Shell
n=82 participants at risk
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
Plasma Coated Acetabular Shell: Plasma HA coated Exceed Acetabular Shell
|
BoneMaster Coated Shell
n=85 participants at risk
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
BoneMaster coated acetabular shell.: Bonemaster coated Exceed Acetabular Shell
|
|---|---|---|
|
Cardiac disorders
Cardiovascular - stroke
|
0.00%
0/82
|
1.2%
1/85
|
|
Musculoskeletal and connective tissue disorders
Fractured pelvis
|
0.00%
0/82
|
1.2%
1/85
|
|
General disorders
Fall - patient confused
|
0.00%
0/82
|
2.4%
2/85
|
|
Renal and urinary disorders
Urogenital adverse event with diarrhoea
|
0.00%
0/82
|
1.2%
1/85
|
|
Renal and urinary disorders
Urogenital
|
0.00%
0/82
|
1.2%
1/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stomach cancer
|
0.00%
0/82
|
1.2%
1/85
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory problems post-op; has COPD
|
0.00%
0/82
|
1.2%
1/85
|
|
General disorders
Antibiotics given imm post-op
|
0.00%
0/82
|
1.2%
1/85
|
|
Blood and lymphatic system disorders
2 units of blood given post-op
|
0.00%
0/82
|
1.2%
1/85
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.2%
1/82
|
0.00%
0/85
|
|
General disorders
Fall - soft tissue injury
|
1.2%
1/82
|
0.00%
0/85
|
|
General disorders
Hernia
|
1.2%
1/82
|
0.00%
0/85
|
|
General disorders
Non-traumatic bruising
|
1.2%
1/82
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Needs scar revised
|
1.2%
1/82
|
0.00%
0/85
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place