Trial Outcomes & Findings for Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup (NCT NCT02062450)
NCT ID: NCT02062450
Last Updated: 2017-05-04
Results Overview
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
COMPLETED
379 participants
2-year postoperative
2017-05-04
Participant Flow
472 patients who underwent hip arthroplasty with a Dual Mobility Cup between September 2010 and December 2011, in the 5 participating centers, have been identified. 379 out of them have been successfully reached by phone to be convoked for their 2-year postoperative follow-up visit. The other 93 patients were considered "lost to follow-up".
Of the 379 contacted patients, 255 came to visit their surgeons for the 2-year follow-up. The other 124 who declined to visit were evaluated by phone for safety criteria.
Participant milestones
| Measure |
Hip Acetabular Replacement, Using a Dual Mobility Cup.
Studied cohort includes 2 subgroups :
* Patients with primary hip replacement.
* Patients with revision surgery.
|
|---|---|
|
Overall Study
STARTED
|
379
|
|
Overall Study
Per Protocol Cohort
|
255
|
|
Overall Study
COMPLETED
|
255
|
|
Overall Study
NOT COMPLETED
|
124
|
Reasons for withdrawal
| Measure |
Hip Acetabular Replacement, Using a Dual Mobility Cup.
Studied cohort includes 2 subgroups :
* Patients with primary hip replacement.
* Patients with revision surgery.
|
|---|---|
|
Overall Study
No follow-up visit
|
124
|
Baseline Characteristics
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
Baseline characteristics by cohort
| Measure |
Primary Surgery
n=191 Participants
Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
|
Revision Surgery
n=64 Participants
Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
71.3 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
72.2 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
191 participants
n=99 Participants
|
64 participants
n=107 Participants
|
255 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2-year postoperativePopulation: 2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Outcome measures
| Measure |
Total Safety Population
n=379 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Number of Participants With an Implant Dislocation After Surgery
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 2-year postoperativeThe primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Outcome measures
| Measure |
Total Safety Population
n=379 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
|
0.53 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 2-year postoperativeImplant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.
Outcome measures
| Measure |
Total Safety Population
n=379 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Implant Survivorship
|
99.5 percentage of implants
|
—
|
SECONDARY outcome
Timeframe: 2 years postoperativePostel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician. It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) : * a score between 15 and 18 points is defined as good, * a score between 12 and 14 points is defined as average, * a score inferior to 12 is defined as bad
Outcome measures
| Measure |
Total Safety Population
n=191 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
n=64 Participants
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Clinical Performance - PMA Score
Baseline
|
10.8 units on a scale
Standard Deviation 2.6
|
9.3 units on a scale
Standard Deviation 3.3
|
|
Clinical Performance - PMA Score
2-y FU visit
|
16.4 units on a scale
Standard Deviation 2.5
|
15.2 units on a scale
Standard Deviation 2.6
|
|
Clinical Performance - PMA Score
Improvement at 2-y FU vs Baseline
|
6.1 units on a scale
Standard Deviation 2.6
|
5.9 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 2 years postoperativeThe HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.
Outcome measures
| Measure |
Total Safety Population
n=191 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
n=64 Participants
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Clinical Performance - HOOS Score
Symptoms
|
87.5 units on a scale of 100
Standard Deviation 15.1
|
84.5 units on a scale of 100
Standard Deviation 13.4
|
|
Clinical Performance - HOOS Score
Daily living
|
84.2 units on a scale of 100
Standard Deviation 22.0
|
76.6 units on a scale of 100
Standard Deviation 18.2
|
|
Clinical Performance - HOOS Score
Sports and recreational activities)
|
63.8 units on a scale of 100
Standard Deviation 33.2
|
43.2 units on a scale of 100
Standard Deviation 27.6
|
|
Clinical Performance - HOOS Score
Pain
|
91.8 units on a scale of 100
Standard Deviation 13.6
|
86.4 units on a scale of 100
Standard Deviation 15.1
|
|
Clinical Performance - HOOS Score
Quality of Life
|
85.2 units on a scale of 100
Standard Deviation 20.5
|
67.0 units on a scale of 100
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 2-year postoperativeThe HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".
Outcome measures
| Measure |
Total Safety Population
n=191 Participants
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Revision Sub-group
n=64 Participants
patients who undergone a revision hip replacement surgery
|
|---|---|---|
|
Clinical Performance - HARRIS Score
Excellent
|
64 percentage of partipants
|
40 percentage of partipants
|
|
Clinical Performance - HARRIS Score
Good
|
13 percentage of partipants
|
16 percentage of partipants
|
|
Clinical Performance - HARRIS Score
Mediocre
|
10 percentage of partipants
|
19 percentage of partipants
|
|
Clinical Performance - HARRIS Score
Poor
|
12 percentage of partipants
|
24 percentage of partipants
|
Adverse Events
Total Safety Population
Primary Surgery Sub-group
Revision Surgery Sub-group
Serious adverse events
| Measure |
Total Safety Population
n=379 participants at risk
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Primary Surgery Sub-group
n=191 participants at risk
Patients who underwent a Primary Hip Replacement surgery
|
Revision Surgery Sub-group
n=64 participants at risk
Patients who underwent a Revision Hip Replacement surgery
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dual Mobility Cup dislocation
|
0.53%
2/379 • Number of events 2 • 2 years postoperative
|
0.52%
1/191 • Number of events 1 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Revision surgery for Implant Mobilisation
|
0.53%
2/379 • Number of events 2 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Revision surgery for Implant Loosening
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.52%
1/191 • Number of events 1 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Revision surgery for Infection
|
0.79%
3/379 • Number of events 3 • 2 years postoperative
|
0.52%
1/191 • Number of events 1 • 2 years postoperative
|
1.6%
1/64 • Number of events 1 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Revision surgery for Implant Malposition
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Revision surgery for Instability
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
1.6%
1/64 • Number of events 1 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Transfemoral Amputation
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Osteosynthesis surgery
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Osteolysis surgery
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
1.6%
1/64 • Number of events 1 • 2 years postoperative
|
Other adverse events
| Measure |
Total Safety Population
n=379 participants at risk
All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
|
Primary Surgery Sub-group
n=191 participants at risk
Patients who underwent a Primary Hip Replacement surgery
|
Revision Surgery Sub-group
n=64 participants at risk
Patients who underwent a Revision Hip Replacement surgery
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Infection without revision surgery
|
1.1%
4/379 • Number of events 4 • 2 years postoperative
|
0.52%
1/191 • Number of events 1 • 2 years postoperative
|
1.6%
1/64 • Number of events 1 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Recurrent Pain
|
0.79%
3/379 • Number of events 3 • 2 years postoperative
|
1.6%
3/191 • Number of events 3 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Wound affection
|
0.79%
3/379 • Number of events 3 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
0.00%
0/64 • 2 years postoperative
|
|
Musculoskeletal and connective tissue disorders
Asymptomatic implant mobilisation
|
0.26%
1/379 • Number of events 1 • 2 years postoperative
|
0.00%
0/191 • 2 years postoperative
|
1.6%
1/64 • Number of events 1 • 2 years postoperative
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60