Degenerative Arthritis, Osteoarthritis, Revision Arthroplasty
Conditions
Brief summary
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ\_2018\_02.
Interventions
DEVICETotal Hip Arthroplasty
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals requiring primary THA for: 1. a severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease). 2. failed previous hip surgery. 3. or dislocation risks. 2. Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes. 3. Individuals who are willing and able to return for follow-up as specified by the study protocol. 4. Individuals who are a minimum age of 21 years at the time of consent. 5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol. \-
Exclusion criteria
1. Individuals have active local or systemic infection. 2. Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s). 4. Individuals with Charcot's or Paget's disease. 5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA. 6. Women who are pregnant or lactating. 7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the 6 months following the time of consent into this study. 8. Individuals that have amputations in either leg that would impact rehabilitation following surgery. 9. Individuals who are bedridden per the Investigators determination 10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months. 11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. 13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia. 14. Subject has a medical condition with less than 2 years life expectancy. 15. Individual has a BMI \>45 kg/m2. 16. Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished neck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superior Cup Migration | 2 years | Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOOS Jr Score | 6 weeks | Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty |
| FJS-12 | 6 weeks | The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome |
| Harris Hip Score | 6 weeks post operative | The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result |
| RSA Measured Subsidence (Superior Cup Migration) | 3 months, 6 months and 1 year | Superior migration of the acetabular cup will be measured using RSA |
| Additional RSA Measurements | 6 weeks, 3 months, 6 months, 1 year and 2 years | Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points |
| Linear Head Penetration | 6 weeks, 1 year, 2 years | Femoral head penetration into the polyethylene liner component will be determined and measured radiographically |
Countries
Canada
Participant flow
Recruitment details
Patients were selected for recruitment into the study from the general diagnosis populations defined as primary total hip arthroplasty (THA) and revision total hip arthroplasty (RTHA). The investigation was conducted at two centers.
Participants by arm
| Arm | Count |
|---|---|
| PINNACLE Dual Mobility System PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications. | 11 |
| PINNACLE Dual Mobility System PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | PINNACLE Dual Mobility System |
|---|---|
| Age, Continuous | 71.1 Years STANDARD_DEVIATION 8.26 |
| Body Mass Index (BMI) | 29.4 kg/m2 STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
Superior Cup Migration
Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)
Time frame: 2 years
Population: Study subjects who reach two years follow-up will undergo radiostereometric analysis of the study hip to determine if the acetabular cup has migrated from its post-operative position. Please note: data is not reported because the study was terminated at 6 weeks, therefore 2-year radiostereometric analyses could not be performed.
Secondary
Additional RSA Measurements
Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points
Time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years
Population: Study subjects who received a PINNACLE Dual Mobility implant. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.
Secondary
FJS-12
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome
Time frame: 6 weeks
Population: All study subjects who received a PINNACLE Dual Mobility Implant were evaluated using the FJS-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superior Acetabular Cup Migration | FJS-12 | 44.4 Units on a scale | Standard Deviation 26 |
Secondary
Harris Hip Score
The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result
Time frame: 6 weeks post operative
Population: All study subjects who received a PINNACLE Dual Mobility implant will have their operative hip assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superior Acetabular Cup Migration | Harris Hip Score | 79.7 units on a scale | Standard Deviation 9.63 |
Secondary
HOOS Jr Score
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty
Time frame: 6 weeks
Population: All study subjects who received a PINNACLE Dual Mobility implant were evaluated using the HOOS Jr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superior Acetabular Cup Migration | HOOS Jr Score | 75.3 Units on a scale | Standard Deviation 10.29 |
Secondary
Linear Head Penetration
Femoral head penetration into the polyethylene liner component will be determined and measured radiographically
Time frame: 6 weeks, 1 year, 2 years
Population: Study subjects who received a Pinnacle Dual Mobility implant will have linear head penetration measured at specified timepoints. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.
Secondary
RSA Measured Subsidence (Superior Cup Migration)
Superior migration of the acetabular cup will be measured using RSA
Time frame: 3 months, 6 months and 1 year
Population: Study subjects who received a PINNACLE Dual Mobility implant. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.