Trial Outcomes & Findings for Exceed ABT Acetabular Cup Cementless System (NCT NCT04255394)
NCT ID: NCT04255394
Last Updated: 2024-07-26
Results Overview
Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: \< 70.
Recruitment status
COMPLETED
Target enrollment
677 participants
Primary outcome timeframe
10 years
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
Group A MoP
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Overall Study
STARTED
|
220
|
457
|
|
Overall Study
Treated
|
208
|
449
|
|
Overall Study
COMPLETED
|
38
|
138
|
|
Overall Study
NOT COMPLETED
|
182
|
319
|
Reasons for withdrawal
| Measure |
Group A MoP
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Overall Study
Death
|
35
|
25
|
|
Overall Study
Device removed
|
2
|
10
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Screen Failure/Not treated
|
12
|
8
|
|
Overall Study
Lost to Follow-up
|
123
|
265
|
|
Overall Study
Adverse Event
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A MoP
n=220 Participants
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=457 Participants
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
Total
n=677 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 5.6 • n=220 Participants
|
61.0 years
STANDARD_DEVIATION 9.3 • n=457 Participants
|
65.8 years
STANDARD_DEVIATION 10.7 • n=677 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=220 Participants
|
284 Participants
n=457 Participants
|
409 Participants
n=677 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=220 Participants
|
173 Participants
n=457 Participants
|
268 Participants
n=677 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
220 Participants
n=220 Participants
|
457 Participants
n=457 Participants
|
677 Participants
n=677 Participants
|
|
Operative Side
Right
|
127 Participants
n=220 Participants
|
238 Participants
n=457 Participants
|
365 Participants
n=677 Participants
|
|
Operative Side
Left
|
93 Participants
n=220 Participants
|
219 Participants
n=457 Participants
|
312 Participants
n=677 Participants
|
|
Diagnosis
Osteoarthritis
|
209 Participants
n=220 Participants
|
411 Participants
n=457 Participants
|
620 Participants
n=677 Participants
|
|
Diagnosis
Other
|
11 Participants
n=220 Participants
|
46 Participants
n=457 Participants
|
57 Participants
n=677 Participants
|
PRIMARY outcome
Timeframe: 10 yearsClinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: \< 70.
Outcome measures
| Measure |
Group A MoP
n=28 Participants
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=134 Participants
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Harris Hip Score
|
89.8 score on a scale
Standard Deviation 11.2
|
90.4 score on a scale
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: 10 yearsClinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here.
Outcome measures
| Measure |
Group A MoP
n=38 Participants
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=148 Participants
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score
|
6.1 score on a scale
Standard Deviation 2.5
|
6.8 score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 10 years post-operativeCalculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative.
Outcome measures
| Measure |
Group A MoP
n=208 Participants
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=449 Participants
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
10 Year Survivorship
|
90.47 percentage of participants
Interval 84.61 to 96.33
|
97.32 percentage of participants
Interval 95.42 to 99.23
|
SECONDARY outcome
Timeframe: 10 yearsThe Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score).
Outcome measures
| Measure |
Group A MoP
n=29 Participants
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=139 Participants
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Oxford Hip Score
|
16.4 score on a scale
Standard Deviation 5.7
|
18.2 score on a scale
Standard Deviation 9.2
|
Adverse Events
Group A MoP
Serious events: 63 serious events
Other events: 1 other events
Deaths: 36 deaths
Group B CoC
Serious events: 89 serious events
Other events: 2 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Group A MoP
n=208 participants at risk
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=449 participants at risk
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
General disorders
Death
|
17.3%
36/208 • Number of events 36 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
5.8%
26/449 • Number of events 26 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
Device Revision
|
7.2%
15/208 • Number of events 15 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
2.2%
10/449 • Number of events 10 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.9%
4/208 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
2.0%
9/449 • Number of events 18 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Fracture of femur or acetabulum
|
1.9%
4/208 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
1.3%
6/449 • Number of events 6 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Trochanteric Bursitis
|
0.96%
2/208 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.89%
4/449 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Total Knee Replacement
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.67%
3/449 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Total Hip replacement contralateral
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.89%
4/449 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Initial cup instability
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.67%
3/449 • Number of events 3 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Noise from the hip
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.89%
4/449 • Number of events 4 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.96%
2/208 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.67%
3/449 • Number of events 3 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.67%
3/449 • Number of events 3 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Facet joint
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.45%
2/449 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Pain syndrom
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.45%
2/449 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Infections and infestations
Infection
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.45%
2/449 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Pain - Intermittent
|
0.48%
1/208 • Number of events 2 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Severe hip pain
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Blood and lymphatic system disorders
Deep vein Trombosis
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Cardiac disorders
Aortic Stenosis
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Nervous system disorders
Sciatic Nerve Encace
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Swelling finger
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Femoral subsidence
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Cardiac disorders
Congestive Heart Failure
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
BILAT BK AMPUTATIONS
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
Ankle replacement
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Calcar Crack
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Injury, poisoning and procedural complications
Injury after fall
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Nervous system disorders
Sciatica
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Nervous system disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Blood and lymphatic system disorders
Sponteneous bleeds
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Trochanteric Pain
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Thigh Pain
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
vertrebral collapse
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Vascular disorders
CVA
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
General disorders
Terminally Ill
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Pain hip
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Groin Discomfort
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
PSOAS Strain
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
Other adverse events
| Measure |
Group A MoP
n=208 participants at risk
Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly)
|
Group B CoC
n=449 participants at risk
Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in left lateral thigh after fall
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Musculoskeletal and connective tissue disorders
Fall on shoulder without injury
|
0.48%
1/208 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.00%
0/449 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
|
Surgical and medical procedures
RIGHT CARPAL TUNNEL DECOMPRESSION
|
0.00%
0/208 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
0.22%
1/449 • Number of events 1 • All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place