Congenital Dislocations, Femur Head Necrosis, Femur Neck Fracture, Post-traumatic Osteoarthritis of Hip Nos, Primary Osteoarthritis
Conditions
Keywords
Arthroplasty, Hip Replacement, Acetabular cup, Dual mobility, Hip revision surgery
Brief summary
The purpose of this study is to demonstrate the performance and reliability of Tornier Dual Mobility Cup used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
Detailed description
The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier Dual Mobility Cup used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed
Interventions
DEVICEPrimary surgery with Dual Mobility Cup
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
DEVICERevision surgery with Dual Mobility Cup
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011, * capable of attending the 2-year follow-up visit; * capable of understanding the information about the study and agreeing to take part in it.
Exclusion criteria
* patients with tumoral pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Implant Dislocation After Surgery | 2-year postoperative | 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. |
| Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate) | 2-year postoperative | 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. |
| Implant Survivorship | 2-year postoperative | Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance - PMA Score | 2 years postoperative | Postel-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 |
| Clinical Performance - HOOS Score | 2 years postoperative | The 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. |
| Clinical Performance - HARRIS Score | 2-year postoperative | The 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Primary Surgery Patients who underwent a primary hip replacement surgery with Dual Mobility Cup | 191 |
| Revision Surgery Patients who underwent a revision hip replacement surgery with Dual Mobility Cup | 64 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No follow-up visit | 124 |
Baseline characteristics
| Characteristic | Primary Surgery | Revision Surgery | Total |
|---|---|---|---|
| Age, Continuous | 72.7 years STANDARD_DEVIATION 9.4 | 71.3 years STANDARD_DEVIATION 11.5 | 72.2 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment France | 191 participants | 64 participants | 255 participants |
| Sex: Female, Male Female | 87 Participants | 33 Participants | 120 Participants |
| Sex: Female, Male Male | 104 Participants | 31 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 379 | 4 / 191 | 2 / 64 |
| serious Total, serious adverse events | 11 / 379 | 2 / 191 | 3 / 64 |
Outcome results
Primary
Implant Survivorship
Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.
Time frame: 2-year postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Safety Population | Implant Survivorship | 99.5 percentage of implants |
Primary
Number of Participants With an Implant Dislocation After Surgery
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.
Time frame: 2-year postoperative
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Safety Population | Number of Participants With an Implant Dislocation After Surgery | 2 participants |
Primary
Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
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.
Time frame: 2-year postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Safety Population | Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate) | 0.53 percentage of participants |
Secondary
Clinical Performance - HARRIS Score
The 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.
Time frame: 2-year postoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Safety Population | Clinical Performance - HARRIS Score | Excellent | 64 percentage of partipants |
| Total Safety Population | Clinical Performance - HARRIS Score | Good | 13 percentage of partipants |
| Total Safety Population | Clinical Performance - HARRIS Score | Mediocre | 10 percentage of partipants |
| Total Safety Population | Clinical Performance - HARRIS Score | Poor | 12 percentage of partipants |
| Revision Sub-group | Clinical Performance - HARRIS Score | Poor | 24 percentage of partipants |
| Revision Sub-group | Clinical Performance - HARRIS Score | Excellent | 40 percentage of partipants |
| Revision Sub-group | Clinical Performance - HARRIS Score | Mediocre | 19 percentage of partipants |
| Revision Sub-group | Clinical Performance - HARRIS Score | Good | 16 percentage of partipants |
Secondary
Clinical Performance - HOOS Score
The 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.
Time frame: 2 years postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Safety Population | Clinical Performance - HOOS Score | Symptoms | 87.5 units on a scale of 100 | Standard Deviation 15.1 |
| Total Safety Population | Clinical Performance - HOOS Score | Sports and recreational activities) | 63.8 units on a scale of 100 | Standard Deviation 33.2 |
| Total Safety Population | Clinical Performance - HOOS Score | Daily living | 84.2 units on a scale of 100 | Standard Deviation 22 |
| Total Safety Population | Clinical Performance - HOOS Score | Quality of Life | 85.2 units on a scale of 100 | Standard Deviation 20.5 |
| Total Safety Population | Clinical Performance - HOOS Score | Pain | 91.8 units on a scale of 100 | Standard Deviation 13.6 |
| Revision Sub-group | Clinical Performance - HOOS Score | Quality of Life | 67.0 units on a scale of 100 | Standard Deviation 26.7 |
| Revision Sub-group | Clinical Performance - HOOS Score | Pain | 86.4 units on a scale of 100 | Standard Deviation 15.1 |
| Revision Sub-group | Clinical Performance - HOOS Score | Symptoms | 84.5 units on a scale of 100 | Standard Deviation 13.4 |
| Revision Sub-group | Clinical Performance - HOOS Score | Daily living | 76.6 units on a scale of 100 | Standard Deviation 18.2 |
| Revision Sub-group | Clinical Performance - HOOS Score | Sports and recreational activities) | 43.2 units on a scale of 100 | Standard Deviation 27.6 |
Secondary
Clinical Performance - PMA Score
Postel-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
Time frame: 2 years postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Safety Population | Clinical Performance - PMA Score | Baseline | 10.8 units on a scale | Standard Deviation 2.6 |
| Total Safety Population | Clinical Performance - PMA Score | 2-y FU visit | 16.4 units on a scale | Standard Deviation 2.5 |
| Total Safety Population | Clinical Performance - PMA Score | Improvement at 2-y FU vs Baseline | 6.1 units on a scale | Standard Deviation 2.6 |
| Revision Sub-group | Clinical Performance - PMA Score | Baseline | 9.3 units on a scale | Standard Deviation 3.3 |
| Revision Sub-group | Clinical Performance - PMA Score | 2-y FU visit | 15.2 units on a scale | Standard Deviation 2.6 |
| Revision Sub-group | Clinical Performance - PMA Score | Improvement at 2-y FU vs Baseline | 5.9 units on a scale | Standard Deviation 3.8 |