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This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.
Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) framework:
Patients:
- Adult men and women requiring a total hip arthroplasty
Intervention:
- THA with SYMBOL CUP DMR HA or SYMBOL CUP DM CEM hemispherical dual mobility acetabular implants.
Comparator: None
Outcomes:
Study design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THA with SYMBOL CUP DMR HA | Device |
| ||
| THA with SYMBOL CUP DM CEM |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival: Acetabular Cup Survival at 2-year Follow-up | 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. | 2 years as of index operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events | All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery. | 2 years as of index operation |
| Harris Hip Score (HHS) at Baseline and 1-year Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Exhaustive recruitment of patients meeting inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Estour, M.D. | Hôpital Privé Medipole de Savoie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Medipole de Savoie | Challes-les-Eaux | 73190 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | HMB-DM-CEM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Implant Survival: Acetabular Cup Survival at 2-year Follow-up | 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. | Posted | Number | 95% Confidence Interval | percentage of implants survival | 2 years as of index operation |
|
Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least)
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical infection | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederic C Daoud, M.D., M.Sc., Epidemiologist-Biostatistician | Medextens SARL | +33964281703 | fcdaoud@medextens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2018 | Feb 5, 2025 | Prot_SAP_000.pdf |
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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 |
| 1 year as of index operation |
| The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | 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 | 2 years as of index operation |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | Kg/m2 |
|
| Operated side | Count of Participants | Participants |
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| Type of surgery | Count of Participants | Participants |
|
| OG001 | 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 |
|
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| Secondary | Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events | All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery. | Posted | Number | participants | 2 years as of index operation |
|
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| Secondary | Harris Hip Score (HHS) at Baseline and 1-year Follow-up | 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 | Number at stake at 1 year take into account the following events (death, lost to follow-up and revisions) | Posted | Median | Standard Deviation | score on a scale | 1 year as of index operation |
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| Secondary | The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | 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 | Number at stake at 1 year or 2-years take into account the following events (death, lost to follow-up and revisions) | Posted | Median | Standard Deviation | score on a scale | 2 years as of index operation |
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| 3 |
| 15 |
| 7 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
| Intra-prosthetic dislocation | Product Issues | Systematic Assessment |
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| fall and fracture of the operated area (Vancouver class: A) | Surgical and medical procedures | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| HHS 1-year |
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| mHHS 1-year |
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| mHHS 2-year |
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