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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary surgery with Dual Mobility Cup | Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup. |
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| Revision surgery with Dual Mobility Cup | Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary surgery with Dual Mobility Cup | Device | Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-year postoperative |
| 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. | 2-year postoperative |
| 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. | 2-year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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) :
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Inclusion Criteria:
Exclusion Criteria:
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The global cohort: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 and who we were able to be contacted by phone.
"Primary replacement" group: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for primary hip replacement and who were seen for their follow-up visit at 2 years post-procedure.
"Revision" group: All patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for revision surgery and who were seen for their follow-up visit at 2 years post-procedure.
All the performance criteria were analysed for the patients in the "Primary replacement" and "Revision" groups
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Hulet, MD, PR | Caen University Hospital, FR | Principal Investigator |
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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.
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".
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| ID | Title | Description |
|---|---|---|
| FG000 | Hip Acetabular Replacement, Using a Dual Mobility Cup. | Studied cohort includes 2 subgroups :
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Revision surgery with Dual Mobility Cup | Device | Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component. |
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| 2 years postoperative |
| 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. | 2 years postoperative |
| 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". | 2-year postoperative |
| Per Protocol Cohort |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 255 patients were included in the Global Study Cohort of which 191 had a Primary Hip surgery and 64 had a Revision Hip surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Surgery | Patients who underwent a primary hip replacement surgery with Dual Mobility Cup |
| BG001 | Revision Surgery | Patients who underwent a revision hip replacement surgery with Dual Mobility Cup |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 2-year postoperative |
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| 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. | Posted | Number | percentage of participants | 2-year postoperative |
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| 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) :
| Posted | Mean | Standard Deviation | units on a scale | 2 years postoperative |
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| 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. | Posted | Mean | Standard Deviation | units on a scale of 100 | 2 years postoperative |
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| 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". | Posted | Number | percentage of partipants | 2-year postoperative |
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| 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. | Posted | Number | percentage of implants | 2-year postoperative |
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2 years postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Safety Population | All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions. | 11 | 379 | 11 | 379 | ||
| EG001 | Primary Surgery Sub-group | Patients who underwent a Primary Hip Replacement surgery | 2 | 191 | 4 | 191 | ||
| EG002 | Revision Surgery Sub-group | Patients who underwent a Revision Hip Replacement surgery | 3 | 64 | 2 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dual Mobility Cup dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Orthopedic reduction only - No Revision surgery |
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| Revision surgery for Implant Mobilisation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision surgery for Implant Loosening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision surgery for Infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision surgery for Implant Malposition | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision surgery for Instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Transfemoral Amputation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Osteosynthesis surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Osteolysis surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection without revision surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Recurrent Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Wound affection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Asymptomatic implant mobilisation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie TRETOUT | TORNIER SAS | +33 4 76 71 35 00 | nathalie.tretout@tornier.com |
| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D012086 | Reoperation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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