Arthroplasty, Replacement, Hip
Conditions
Keywords
Osteoarthritis, Traumatic arthritis, Avascular Necrosis
Brief summary
This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface. The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.
Detailed description
The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study. A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer. Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
Interventions
DEVICETritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell in total hip replacement.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A. Patient has signed an IRB approved, study specific Informed Patient Consent Form. * B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation. * C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). * D. Patient is a candidate for a primary cementless total hip replacement. * E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
* F. Patient has a Body Mass Index (BMI) ≥ 40. * G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. * J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. * L. Patient has a known sensitivity to device materials. * M. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Acetabular Revision | 5 years | To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 1, 3, and 5 years | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor |
| Short Form- 12 (SF-12) Heath Survey Scores | 1, 3, and 5 years | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Lower Extremity Activity Scale (LEAS) Score | 1, 3, and 5 years | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
| Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell | Intraoperative | Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study). |
| Follow-Up Questionnaire | 6, 7, 8, 9, and 10 years | The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions: * Patient satisfaction with the hip replacement * Presence of any pain in the study hip * Any surgeries performed on the study hip |
| Acetabular Shell Radiographic Stability | 6 weeks, 1, 3, 5 years | Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable. |
| EuroQol Five-Dimensional (EQ-5D) | 1,2,3,4, and 5 years | The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. The index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health. |
Countries
United States
Participant flow
Pre-assignment details
275 participants/284 hip cases were enrolled. There were 266 unilateral hip cases and 9 bilateral hips cases.
Participants by arm
| Arm | Count |
|---|---|
| Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement. | 234 |
| Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement. | 241 |
| Total | 475 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Cases terminated due to investigator leaving the site and site closure. | 35 |
| Overall Study | Censored from analyses | 42 |
| Overall Study | Death | 13 |
| Overall Study | Investigator site closed | 10 |
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Revision | 6 |
| Overall Study | Sponsored Terminated Study | 60 |
| Overall Study | Withdrawal by Subject | 34 |
Baseline characteristics
| Characteristic | Tritanium® Primary Acetabular Shell |
|---|---|
| Age, Continuous | 62.60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 207 Participants |
| Region of Enrollment United States | 241 Cases |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 241 | 13 / 234 |
| other Total, other adverse events | 61 / 241 | 0 / 234 |
| serious Total, serious adverse events | 16 / 241 | 56 / 234 |
Outcome results
Primary
Absence of Acetabular Revision
To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Tritanium® Primary Acetabular Shell | Absence of Acetabular Revision | 6 hips |
Secondary
Acetabular Shell Radiographic Stability
Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.
Time frame: 6 weeks, 1, 3, 5 years
Population: Frequency of the acetabular shell stability.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 6- Weeks Postoperative: Stable | 227 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 6- Weeks Postoperative: Fibrous Stable | 0 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 6- Weeks Postoperative: Unstable | 0 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 1-Year Postoperative: Stable | 192 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 1-Year Postoperative: Fibrous Stable | 2 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 1-Year Postoperative: Unstable | 0 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 3-Years Postoperative: Stable | 130 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 3-Years Postoperative: Fibrous Stable | 4 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 3-Years Postoperative: Unstable | 0 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 5-Years Postoperative: Stable | 85 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 5-Years Postoperative: Fibrous Stable | 3 Hips |
| Tritanium® Primary Acetabular Shell | Acetabular Shell Radiographic Stability | 5-Years Postoperative: Unstable | 3 Hips |
Secondary
EuroQol Five-Dimensional (EQ-5D)
The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. The index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health.
Time frame: 1,2,3,4, and 5 years
Population: A calculable case is one where all data points are present to calculate the stated score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 1-Year EQ5D Health State Over Time | 79.87 Score on a scale | Standard Deviation 17.32 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 1-Year EQ5D TTO Valuation Over Time | .87 Score on a scale | Standard Deviation 0.16 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 2-Year EQ5D Health State Over Time | 79.87 Score on a scale | Standard Deviation 17.01 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 2-Year EQ5D TTO Valuation Over Time | .84 Score on a scale | Standard Deviation 0.18 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 3-Year EQ5D Health State Over Time | 82.75 Score on a scale | Standard Deviation 13.62 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 3-Year EQ5D TTO Valuation Over Time | .88 Score on a scale | Standard Deviation 0.15 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 4-Year EQ5D Health State Over Time | 80.8 Score on a scale | Standard Deviation 15.55 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 4-Year EQ5D TTO Valuation Over Time | .86 Score on a scale | Standard Deviation 0.14 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 5-Year EQ5D Health State Over Time | 80.95 Score on a scale | Standard Deviation 16.78 |
| Tritanium® Primary Acetabular Shell | EuroQol Five-Dimensional (EQ-5D) | 5-Year EQ5D TTO Valuation Over Time | .86 Score on a scale | Standard Deviation 0.15 |
Secondary
Follow-Up Questionnaire
The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions: * Patient satisfaction with the hip replacement * Presence of any pain in the study hip * Any surgeries performed on the study hip
Time frame: 6, 7, 8, 9, and 10 years
Population: Not all participants completed the Follow-Up Questionnaire at the respective timepoints.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES | 25 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO | 74 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES | 96 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO | 3 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES | 1 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO | 98 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES | 25 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO | 64 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES | 86 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO | 3 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES | 0 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO | 89 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES | 14 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO | 50 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES | 61 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO | 3 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES | 0 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO | 64 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES | 8 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO | 31 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES | 38 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO | 1 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES | 0 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO | 39 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES | 6 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO | 37 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES | 41 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO | 2 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES | 0 Hips |
| Tritanium® Primary Acetabular Shell | Follow-Up Questionnaire | 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO | 43 Hips |
Secondary
Harris Hip Score
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Time frame: 1, 3, and 5 years
Population: A calculable HHS score is a case where all data points are present to calculate the stated score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Harris Hip Score | 1-Year Harris Hip Score | 90.01 Score on a scale | Standard Deviation 13.6 |
| Tritanium® Primary Acetabular Shell | Harris Hip Score | 3-Year Harris Hip Score | 90.99 Score on a scale | Standard Deviation 13.64 |
| Tritanium® Primary Acetabular Shell | Harris Hip Score | 5-Year Harris Hip Score | 90.7 Score on a scale | Standard Deviation 14.37 |
Secondary
Lower Extremity Activity Scale (LEAS) Score
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: 1, 3, and 5 years
Population: An evaluable case is one where all data points are present to calculate the stated score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Lower Extremity Activity Scale (LEAS) Score | 1-Year LEAS | 10.74 Score on a scale | Standard Deviation 3.06 |
| Tritanium® Primary Acetabular Shell | Lower Extremity Activity Scale (LEAS) Score | 3-Year LEAS | 11.61 Score on a scale | Standard Deviation 3.11 |
| Tritanium® Primary Acetabular Shell | Lower Extremity Activity Scale (LEAS) Score | 5-Year LEAS | 11.11 Score on a scale | Standard Deviation 3.41 |
Secondary
Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell
Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study).
Time frame: Intraoperative
Population: Bone screws used.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell | Yes | 178 Hips |
| Tritanium® Primary Acetabular Shell | Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell | No | 63 Hips |
Secondary
Short Form- 12 (SF-12) Heath Survey Scores
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: 1, 3, and 5 years
Population: An evaluable case is one where all data points are present to calculate the stated score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 5-Year Mental Component Score | 55.34 Score on a scale | Standard Deviation 7.78 |
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 1-Year Physical Component Score | 46.77 Score on a scale | Standard Deviation 10.45 |
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 1-Year Mental Component Score | 55.26 Score on a scale | Standard Deviation 8.95 |
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 3-Year Physical Component Score | 46.62 Score on a scale | Standard Deviation 10.48 |
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 3-Year Mental Component Score | 55.63 Score on a scale | Standard Deviation 8.51 |
| Tritanium® Primary Acetabular Shell | Short Form- 12 (SF-12) Heath Survey Scores | 5-Year Physical Component Score | 46.68 Score on a scale | Standard Deviation 10.38 |