Trial Outcomes & Findings for A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads (NCT NCT02525627)
NCT ID: NCT02525627
Last Updated: 2024-02-22
Results Overview
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
5 years follow-up
Results posted on
2024-02-22
Participant Flow
40 participants/hips - 6 participants/hips excluded during surgery = 34 participants/hips
Participant milestones
| Measure |
Trident Cup, X3 Inserts, 28 mm Head
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Trident Cup, X3 Inserts, 40 mm Head
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
Trident Cup, X3 Inserts, 28 mm Head
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Trident Cup, X3 Inserts, 40 mm Head
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
|---|---|---|
|
Overall Study
Revision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Site terminated
|
11
|
10
|
Baseline Characteristics
Data not available for all participants
Baseline characteristics by cohort
| Measure |
Trident Cup, X3 Inserts, 28 mm Head
n=16 Participants
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Trident Cup, X3 Inserts, 40 mm Head
n=18 Participants
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.67 years
STANDARD_DEVIATION 4.68 • n=16 Participants
|
62.91 years
STANDARD_DEVIATION 6.25 • n=18 Participants
|
64.68 years
STANDARD_DEVIATION 5.87 • n=34 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=12 Participants • Data not available for all participants
|
10 Participants
n=13 Participants • Data not available for all participants
|
18 Participants
n=25 Participants • Data not available for all participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=12 Participants • Data not available for all participants
|
3 Participants
n=13 Participants • Data not available for all participants
|
7 Participants
n=25 Participants • Data not available for all participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=16 Participants
|
18 participants
n=18 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: 5 years follow-upPopulation: Wear data were not measured at the investigation site.
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1, 2 and 5 yearsPopulation: Participants with available data. Overall number of participants analysed is based upon the 6 week population.
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.
Outcome measures
| Measure |
Trident Cup, X3 Inserts, 28 mm Head
n=13 Participants
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Trident Cup, X3 Inserts, 40 mm Head
n=15 Participants
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
|---|---|---|
|
Harris Hip Score (HHS) Patient Questionnaire
6 weeks HHS
|
82.89 units on a scale
Standard Deviation 11.38
|
85.73 units on a scale
Standard Deviation 7.91
|
|
Harris Hip Score (HHS) Patient Questionnaire
3 months HHS
|
87.06 units on a scale
Standard Deviation 12.03
|
92.60 units on a scale
Standard Deviation 4.08
|
|
Harris Hip Score (HHS) Patient Questionnaire
1 year HHS
|
91.71 units on a scale
Standard Deviation 6.14
|
92.76 units on a scale
Standard Deviation 4.30
|
|
Harris Hip Score (HHS) Patient Questionnaire
2 years HHS
|
90.48 units on a scale
Standard Deviation 6.05
|
92.63 units on a scale
Standard Deviation 6.81
|
|
Harris Hip Score (HHS) Patient Questionnaire
5 years HHS
|
92.36 units on a scale
Standard Deviation 6.56
|
85.95 units on a scale
Standard Deviation 21.43
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1, 2 and 5 yearsPopulation: Merle D'Aubergine Score (MdA) data were not measured at the investigation site.
The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor \<13.
Outcome measures
Outcome data not reported
Adverse Events
Trident Cup, X3 Inserts, 28 mm Head
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Trident Cup, X3 Inserts, 40 mm Head
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trident Cup, X3 Inserts, 28 mm Head
n=16 participants at risk
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
Trident Cup, X3 Inserts, 40 mm Head
n=18 participants at risk
Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Luxation of hip prosthesis
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
5.6%
1/18 • Number of events 1 • Up to 5 years post-operative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Tumor
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
0.00%
0/18 • Up to 5 years post-operative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowel Cancer
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
0.00%
0/18 • Up to 5 years post-operative
|
|
Cardiac disorders
Cardiac Arrhythmia
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
0.00%
0/18 • Up to 5 years post-operative
|
|
Musculoskeletal and connective tissue disorders
Intraoperative Trochanter Fracture
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
0.00%
0/18 • Up to 5 years post-operative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma
|
0.00%
0/16 • Up to 5 years post-operative
|
5.6%
1/18 • Number of events 1 • Up to 5 years post-operative
|
|
Infections and infestations
Superficial infection
|
6.2%
1/16 • Number of events 1 • Up to 5 years post-operative
|
0.00%
0/18 • Up to 5 years post-operative
|
Other adverse events
Adverse event data not reported
Additional Information
Doug McGurty
Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands
Phone: +44 (0) 1635 500690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60