Primary Total Hip Arthroplasty, Revision Total Hip Arthroplasty
Conditions
Keywords
total hip arthroplasty, complex, revision, hemispherical dual-mobility acetabular cup, safety, efficacy, implant survival, prosthetic dislocation
Brief summary
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.
Detailed description
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: * Safety 1: Implant survival over 2-year follow-up. * Safety 2: All adverse events, with focus on implant dislocation, infections, revision surgery * Efficacy 1: Harris Hip Score (HHS) at baseline and 1-year follow-up. * Efficacy 2: Modified HHS (mHHS) consisting of pain + functional subscores at baseline, 1-year and 2-year follow-ups. * Efficacy 2: Devane score at baseline, 1-year and 2-year follow-ups. * Efficacy 3: Charnley classification at baseline, 1-year and 2-year followups. Study design: * single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 2 years prior to study start. * Prospective 2-year follow-up letter and phone questionnaire.
Interventions
DEVICETHA with SYMBOL CUP DMR HA
DEVICETHA with SYMBOL CUP DM CEM
Sponsors
Dedienne Sante S.A.S.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with total hip implant using hemispheric dual-mobility SYMBOL CUP DMR HA or SYMBOL CUP DM CEM * Operation performed by the primary investigator * Delay between index operation and March 1 2018 has reached 2 years
Exclusion criteria
* patient refusal to participate in the study * minors (age \< 18 years) * patients under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival: Acetabular Cup Survival at 2-year Follow-up | 2 years as of index operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events | 2 years as of index operation | All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery. |
| Harris Hip Score (HHS) at Baseline and 1-year Follow-up | 1 year as of index operation | 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 |
| The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | 2 years as of index operation | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 5 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | HMB-DMR-HA | HMB-DM-CEM | Total |
|---|---|---|---|
| Age, Continuous | 77.3 years STANDARD_DEVIATION 33.4 | 77.6 years STANDARD_DEVIATION 6.7 | 77.4 years STANDARD_DEVIATION 26.7 |
| BMI | 24.4 Kg/m2 STANDARD_DEVIATION 4.8 | 25.8 Kg/m2 STANDARD_DEVIATION 2.4 | 24.8 Kg/m2 STANDARD_DEVIATION 4.2 |
| Operated side Left | 5 Participants | 3 Participants | 8 Participants |
| Operated side Right | 10 Participants | 2 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 15 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
| Type of surgery rTHA | 10 Participants | 5 Participants | 15 Participants |
| Type of surgery THA | 5 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 15 | 0 / 5 |
| other Total, other adverse events | 0 / 15 | 0 / 5 |
| serious Total, serious adverse events | 7 / 15 | 0 / 5 |
Outcome results
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.
Time frame: 2 years as of index operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HMB-DMR-HA | Implant Survival: Acetabular Cup Survival at 2-year Follow-up | 94.7 percentage of implants survival |
| HMB-DM-CEM | Implant Survival: Acetabular Cup Survival at 2-year Follow-up | 100 percentage of implants survival |
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
Time frame: 1 year as of index operation
Population: Number at stake at 1 year take into account the following events (death, lost to follow-up and revisions)
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| HMB-DMR-HA | Harris Hip Score (HHS) at Baseline and 1-year Follow-up | HHS preoperative | 34 score on a scale | Standard Deviation 37.7 |
| HMB-DMR-HA | Harris Hip Score (HHS) at Baseline and 1-year Follow-up | HHS 1-year | 89 score on a scale | Standard Deviation 24 |
| HMB-DM-CEM | Harris Hip Score (HHS) at Baseline and 1-year Follow-up | HHS preoperative | 58 score on a scale | Standard Deviation 13.8 |
| HMB-DM-CEM | Harris Hip Score (HHS) at Baseline and 1-year Follow-up | HHS 1-year | 86 score on a scale | Standard Deviation 34.2 |
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.
Time frame: 2 years as of index operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HMB-DMR-HA | 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 |
| HMB-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 | 0 participants |
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
Time frame: 2 years as of index operation
Population: Number at stake at 1 year or 2-years take into account the following events (death, lost to follow-up and revisions)
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| HMB-DMR-HA | 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 |
| HMB-DMR-HA | 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 |
| HMB-DMR-HA | 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 |
| HMB-DM-CEM | The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | mHHS preoperative | 49 score on a scale | Standard Deviation 13.4 |
| HMB-DM-CEM | The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | mHHS 1-year | 77 score on a scale | Standard Deviation 34.2 |
| HMB-DM-CEM | The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up | mHHS 2-year | 80 score on a scale | Standard Deviation 10 |