Trial Outcomes & Findings for 28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study (NCT NCT00208507)
NCT ID: NCT00208507
Last Updated: 2023-11-07
Results Overview
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
264 participants
Primary outcome timeframe
The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)
Results posted on
2023-11-07
Participant Flow
Patients were selected for recruitment into the study from the general diagnosis population defined as "primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD)." The investigation was conducted at 8 centers. Each center randomly assigned patients to both the investigational and control treatment groups.
Participant milestones
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
87
|
|
Overall Study
COMPLETED
|
163
|
79
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
Baseline characteristics by cohort
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
n=177 Participants
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
n=87 Participants
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Region of Enrollment
United States · United States
|
177 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
Outcome measures
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
n=177 Participants
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
n=87 Participants
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
|---|---|---|
|
Harris Hip Total Score
6 weeks
|
75.7 Units on a scale
Standard Deviation 12.3
|
73.6 Units on a scale
Standard Deviation 12.7
|
|
Harris Hip Total Score
6 months
|
92.2 Units on a scale
Standard Deviation 11.4
|
91.4 Units on a scale
Standard Deviation 11.6
|
|
Harris Hip Total Score
last follow up of 24 months or greater
|
94.6 Units on a scale
Standard Deviation 9.3
|
94.5 Units on a scale
Standard Deviation 8.0
|
|
Harris Hip Total Score
Pre-operative
|
50.5 Units on a scale
Standard Deviation 9.6
|
50.8 Units on a scale
Standard Deviation 9.5
|
|
Harris Hip Total Score
12 months
|
94.2 Units on a scale
Standard Deviation 10.1
|
93.7 Units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)Population: Complication Rates are contained in the Adverse Events Tab and include all reported complications in all patients as represented in the Final Clinical Study Report
Complication Rates are reported by each type of complication (adverse events/AEs) in the Adverse Events Tab
Outcome measures
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
n=177 Participants
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
n=87 Participants
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
|---|---|---|
|
Complication Rates
|
567 Complications
|
287 Complications
|
Adverse Events
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
Serious events: 27 serious events
Other events: 80 other events
Deaths: 4 deaths
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
Serious events: 14 serious events
Other events: 44 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
n=177 participants at risk
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
n=87 participants at risk
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
|
Endocrine disorders
Endocrine/Metabolic
|
0.56%
1/177 • Number of events 1
|
2.3%
2/87 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.1%
2/177 • Number of events 2
|
2.3%
2/87 • Number of events 2
|
|
Injury, poisoning and procedural complications
Dislocation
|
0.00%
0/177
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
9.0%
16/177 • Number of events 16
|
9.2%
8/87 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.7%
3/177 • Number of events 3
|
2.3%
2/87 • Number of events 2
|
|
Nervous system disorders
Neurological
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
|
Renal and urinary disorders
Genitourinary
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
|
Surgical and medical procedures
Acetabular liner failure
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
|
Surgical and medical procedures
Femoral Component Loosening
|
0.56%
1/177 • Number of events 1
|
0.00%
0/87
|
Other adverse events
| Measure |
Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System
n=177 participants at risk
The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
Pinnacle™ Acetabular Cup With Marathon® Polyethylene
n=87 participants at risk
Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
6.2%
11/177 • Number of events 11
|
6.9%
6/87 • Number of events 6
|
|
Injury, poisoning and procedural complications
Wound Problem
|
5.1%
9/177 • Number of events 9
|
2.3%
2/87 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
38.4%
68/177 • Number of events 68
|
41.4%
36/87 • Number of events 36
|
|
Renal and urinary disorders
Genitourinary
|
5.6%
10/177 • Number of events 10
|
8.0%
7/87 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER