Not provided
Not provided
Not provided
Not provided
Business decision made not to fund study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Arthroplasty | Experimental | Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
|
| Revision Total Hip Arthroplasty | Experimental | Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Device | Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
| Measure | Description | Time Frame |
|---|---|---|
| Superior Cup Migration | Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Individuals requiring primary THA for:
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.
Individuals who are willing and able to return for follow-up as specified by the study protocol.
Individuals who are a minimum age of 21 years at the time of consent.
Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba | Winnipeg | Manitoba | Canada | |||
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at https://yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Superior Cup Migration | Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM) | 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. | Posted | 2 years | mm | mm |
|
|
Adverse events were collected up to the six-week time point
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Avulsion fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
Study was terminated prior to subjects reaching three-month timepoint; therefore, only secondary endpoint data at six-weeks was collected. RSA evaluations are performed once all subjects have completed follow-up at a protocol prescribed timepoint. Since the study was terminated following the enrollment of eleven subjects, no RSA evaluations took place.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Whalen | DePuy Synthes | 574-404-9399 | dwhalen@its.jnj.com |
Not provided
| 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 | Mar 4, 2022 | Dec 20, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Revision Total Hip Arthroplasty | Device | Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
|
|
| 6 weeks post operative |
| 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 | 6 weeks |
| 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 | 6 weeks |
| Linear Head Penetration | Femoral head penetration into the polyethylene liner component will be determined and measured radiographically | 6 weeks, 1 year, 2 years |
| RSA Measured Subsidence (Superior Cup Migration) | Superior migration of the acetabular cup will be measured using RSA | 3 months, 6 months and 1 year |
| 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 | 6 weeks, 3 months, 6 months, 1 year and 2 years |
| QEII Health Sciences Centre & Dalhousie University |
| Halifax |
| Nova Scotia |
| Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Hips |
|
| Years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Body Mass Index (BMI) | A measurement was missed for one participant and BMI could not be calculated | Mean | Standard Deviation | kg/m2 | Participants |
|
|
| Participants |
|
| mm |
|
| 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 | All study subjects who received a PINNACLE Dual Mobility implant will have their operative hip assessed | Posted | Mean | Standard Deviation | units on a scale | 6 weeks post operative | Hips | Hips |
|
|
|
| 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 | All study subjects who received a PINNACLE Dual Mobility implant were evaluated using the HOOS Jr | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks | Hip | Hip |
|
|
|
| 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 | All study subjects who received a PINNACLE Dual Mobility Implant were evaluated using the FJS-12 | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks | Hip | Hip |
|
|
|
| Secondary | Linear Head Penetration | Femoral head penetration into the polyethylene liner component will be determined and measured radiographically | 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. | Posted | 6 weeks, 1 year, 2 years | hips | hips |
|
|
| Secondary | RSA Measured Subsidence (Superior Cup Migration) | Superior migration of the acetabular cup will be measured using RSA | 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. | Posted | 3 months, 6 months and 1 year | Hips | Hips |
|
|
| 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 | 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. | Posted | 6 weeks, 3 months, 6 months, 1 year and 2 years | Hips | Hips |
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 2 |
| 11 |
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |