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Sponsor decision to terminate early. Decision was not based on safety or efficacy of the study product.
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The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell 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. This will be summarized for each surgical approach separately, as well as combined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Approach | Experimental | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach |
|
| Lateral Approach | Experimental | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach |
|
| Anterior Approach | Experimental | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THA | Device | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined | At 6 week and 2 years |
| Patient Reported Outcome Measures (PROMs)- HOOS Jr. | Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome). | Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years |
| Patient Reported Outcome Measures (PROMs)- 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 with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness. | At 6 weeks, 3 months, 6 months, 1 year and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | At 3 months, 6 months and 1 year | |
| Other RSA Measurements (X-Translations) | Other RSA measurements (X translations in mm) at all time points |
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Inclusion Criteria:
Exclusion Criteria:
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| 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
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Out of total 100 participants enrolled, 84 participants underwent surgery via either posterior, lateral, or anterior approach. The remaining 16 participants were either withdrawn prior to surgery or the study was terminated prior to surgery and thus they were not included in a surgical approach group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Posterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach. |
| FG001 | Lateral Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach. |
| FG002 | Anterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all enrolled participants who received total hip arthroplasty (THA) surgery. Participants were analyzed according to the surgical approach applied during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Posterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach |
| BG001 | Lateral Approach |
| 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 | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | mm | At 6 week and 2 years |
|
Day 0 up to 2 years
Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
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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 | Posterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iliotibial band syndrome | Injury, poisoning and procedural complications | MedDra21.1 | Non-systematic Assessment |
Early Termination of the study; study was not terminated due to saftey concerns with the product.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Panozzo | JnJ MedTech | +15744049398 | MPanozzo@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2022 | Aug 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2021 | Aug 18, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| At 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Other RSA Measurements (Z-Translations) | Other RSA measurements (Z translations in mm) at all time points | At 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Other RSA Measurements (Rotations) | X, Y, and Z rotations in degrees at all time points | At 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Linear Head Penetration | Linear head penetration at 1 year and 2 years for each surgical approach separately was reported. | At 1 year and 2 years |
| Patient Reported Outcome Measures (PROMs)- 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. | Pre Operation (-Day90 to Day 0), At 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 |
| Withdrawal by Subject |
|
| Inclusion/Exclusion Criteria not met |
|
| Other |
|
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach
| BG002 | Anterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Safety Analysis Set | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Primary Diagnosis | Safety Analysis Set | Count of Participants | Participants |
|
| BMI | Safety Analysis Set | Mean | Standard Deviation | kg/m2 |
|
| OG002 | Anterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach |
| OG003 | Overall Population | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach. |
|
|
| Secondary | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | mm | At 3 months, 6 months and 1 year |
|
|
|
| Secondary | Other RSA Measurements (X-Translations) | Other RSA measurements (X translations in mm) at all time points | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | mm | At 6 weeks, 3 months, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Other RSA Measurements (Z-Translations) | Other RSA measurements (Z translations in mm) at all time points | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | mm | At 6 weeks, 3 months, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Other RSA Measurements (Rotations) | X, Y, and Z rotations in degrees at all time points | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | Degrees | At 6 weeks, 3 months, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Linear Head Penetration | Linear head penetration at 1 year and 2 years for each surgical approach separately was reported. | Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis. | Posted | Mean | Standard Deviation | mm | At 1 year and 2 years |
|
|
|
| Secondary | Patient Reported Outcome Measures (PROMs)- 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. | Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis. | Posted | Mean | Standard Deviation | Units on a scale | Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years |
|
|
|
| Primary | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome). | Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis. | Posted | Mean | Standard Deviation | Units on a scale | Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years |
|
|
|
| Primary | Patient Reported Outcome Measures (PROMs)- 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 with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness. | Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis. | Posted | Mean | Standard Deviation | Units on a scale | At 6 weeks, 3 months, 6 months, 1 year and 2 years |
|
|
|
| 1 |
| 40 |
| 8 |
| 40 |
| 9 |
| 40 |
| EG001 | Lateral Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach | 0 | 20 | 2 | 20 | 4 | 20 |
| EG002 | Anterior Approach | Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach | 0 | 24 | 5 | 24 | 7 | 24 |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDra 21.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDra 21.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Adrenocortical carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.1 | Non-systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDra 21.1 | Non-systematic Assessment |
|
| Incision site discharge | Injury, poisoning and procedural complications | MedDra21.1 | Non-systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDra21.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDra21.1 | Non-systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDra21.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Limb asymmetry | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDra21.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDra21.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDra21.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDra21.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDra21.1 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra21.1 | Non-systematic Assessment |
|
| Stitch abscess | Infections and infestations | MedDra21.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDra21.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDra21.1 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDra21.1 | Non-systematic Assessment |
|
Not provided
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| Male |
|
| Avascular necrosis |
|
| Degenerative Joint Disease |
|
|
|
| RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up |
|
|
| RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up |
|
|
|
| X-axis translations (mm) at 3 months |
|
|
| X-axis translations (mm) at 6 months |
|
|
| X-axis translations (mm) at 1 year |
|
|
| X-axis translations (mm) at 2 years |
|
|
|
| Z-axis translations (mm) at 3 months |
|
|
| Z-axis translations (mm) at 6 months |
|
|
| Z-axis translations (mm) at 1 year |
|
|
| Z-axis translations (mm) at 2 years |
|
|
|
| Y-axis Rotation at 6 weeks |
|
|
| Z-axis Rotation at 6 weeks |
|
|
| X-axis Rotation at 3 months |
|
|
| Y-axis Rotation at 3 months |
|
|
| Z-axis Rotation at 3 months |
|
|
| X-axis Rotation at 6 months |
|
|
| Y-axis Rotation at 6 months |
|
|
| Z-axis Rotation at 6 months |
|
|
| X-axis Rotation at 1 year |
|
|
| Y-axis Rotation at 1 year |
|
|
| Z-axis Rotation at 1 year |
|
|
| X-axis Rotation at 2 years |
|
|
| Y-axis Rotation at 2 years |
|
|
| Z-axis Rotation at 2 years |
|
|
| Linear Head Penetration at 2 years f/up |
|
|
| HHS at 6 weeks follow-up |
|
|
| HHS at 3 months follow-up |
|
|
| HHS at 6 months follow-up |
|
|
| HHS at 1 year follow-up |
|
|
| HHS at 2 years follow-up |
|
|
| HOOS Jr. at 6 weeks follow-up |
|
|
| HOOS Jr. at 3 months follow-up |
|
|
| HOOS Jr. at 6 months follow-up |
|
|
| HOOS Jr. at 1 year follow-up |
|
|
| HOOS Jr. at 2 years follow-up |
|
|
| FJS-12 Score at 3 months follow-up |
|
|
| FJS-12 Score at 6 months follow-up |
|
|
| FJS-12 Score at 1 year follow-up |
|
|
| FJS-12 Score at 2 years follow-up |
|
|