Trial Outcomes & Findings for Retrospective Observational Cohort Study of SYMBOL CUP DM 2 (NCT NCT04209426)
NCT ID: NCT04209426
Last Updated: 2025-04-18
Results Overview
This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the acetabular prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.
COMPLETED
20 participants
2 years as of index operation
2025-04-18
Participant Flow
Participant milestones
| Measure |
HMB-DMR-HA
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
|
Overall Study
COMPLETED
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
HMB-DMR-HA
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HMB-DMR-HA
n=15 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.3 years
STANDARD_DEVIATION 33.4 • n=15 Participants
|
77.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
77.4 years
STANDARD_DEVIATION 26.7 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
15 participants
n=15 Participants
|
5 participants
n=5 Participants
|
20 participants
n=20 Participants
|
|
BMI
|
24.4 Kg/m2
STANDARD_DEVIATION 4.8 • n=15 Participants
|
25.8 Kg/m2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
24.8 Kg/m2
STANDARD_DEVIATION 4.2 • n=20 Participants
|
|
Operated side
Right
|
10 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
|
Operated side
Left
|
5 Participants
n=15 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
|
Type of surgery
THA
|
5 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
|
Type of surgery
rTHA
|
10 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 2 years as of index operationThis is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the acetabular prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.
Outcome measures
| Measure |
HMB-DMR-HA
n=15 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Implant Survival: Acetabular Cup Survival at 2-year Follow-up
|
94.7 percentage of implants survival
Interval 68.1 to 99.2
|
100 percentage of implants survival
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 years as of index operationAll serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery.
Outcome measures
| Measure |
HMB-DMR-HA
n=15 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events
|
10 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year as of index operationPopulation: Number at stake at 1 year take into account the following events (death, lost to follow-up and revisions)
Harris Hip Score (HHS) is measured at each assessment in each patient. HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability). The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments
Outcome measures
| Measure |
HMB-DMR-HA
n=15 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Harris Hip Score (HHS) at Baseline and 1-year Follow-up
HHS preoperative
|
34 score on a scale
Standard Deviation 37.7
|
58 score on a scale
Standard Deviation 13.8
|
|
Harris Hip Score (HHS) at Baseline and 1-year Follow-up
HHS 1-year
|
89 score on a scale
Standard Deviation 24
|
86 score on a scale
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: 2 years as of index operationPopulation: Number at stake at 1 year or 2-years take into account the following events (death, lost to follow-up and revisions)
The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. It consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points). Scores range from 0 (worse disability) to 91 (less disability)The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments
Outcome measures
| Measure |
HMB-DMR-HA
n=15 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 Participants
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up
mHHS preoperative
|
29 score on a scale
Standard Deviation 21.5
|
49 score on a scale
Standard Deviation 13.4
|
|
The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up
mHHS 1-year
|
80 score on a scale
Standard Deviation 22.5
|
77 score on a scale
Standard Deviation 34.2
|
|
The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up
mHHS 2-year
|
87 score on a scale
Standard Deviation 11.3
|
80 score on a scale
Standard Deviation 10.0
|
Adverse Events
HMB-DMR-HA
HMB-DM-CEM
Serious adverse events
| Measure |
HMB-DMR-HA
n=15 participants at risk
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.
THA with SYMBOL CUP DMR HA
|
HMB-DM-CEM
n=5 participants at risk
Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.
THA with SYMBOL CUP DM CEM
|
|---|---|---|
|
Surgical and medical procedures
Surgical infection
|
13.3%
2/15 • Number of events 2 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
0.00%
0/5 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
|
Product Issues
Intra-prosthetic dislocation
|
6.7%
1/15 • Number of events 1 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
0.00%
0/5 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
|
Surgical and medical procedures
fall and fracture of the operated area (Vancouver class: A)
|
6.7%
1/15 • Number of events 1 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
0.00%
0/5 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
|
General disorders
Other
|
20.0%
3/15 • Number of events 3 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
0.00%
0/5 • Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
|
Other adverse events
Adverse event data not reported
Additional Information
Frederic C Daoud, M.D., M.Sc., Epidemiologist-Biostatistician
Medextens SARL
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place