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As longitudinal patient follow-up continues to lag, it has been determined that the study is no longer able to meet its objectives.
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The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.
This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component.
Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restoration ADM X3 Device | Other | Restoration ADM X3 Device in total hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restoration ADM X3 Device | Device | Restoration ADM X3 Device in total hip replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Defined as absence of postoperative femoral head dislocation. | 10 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) Score Improvement From Preoperative 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Hedley, M.D. | Arizona Institute for Bone & Joint Disorders | Principal Investigator |
| Kipling Sharpe, M.D. | OrthoArizona | Principal Investigator |
| Craig J. Della Valle, M.D. | Rush University Medical Center | Principal Investigator |
| Geoffrey Westrich, M.D. | Hospital for Special Surgery, New York | Principal Investigator |
| Joseph Nessler, M.D. | St. Cloud Orthopedic Associates | Principal Investigator |
| Brian C de Beaubien, M.D. | Covenant Medical Center | Principal Investigator |
| Christoph Lohmann, MD | Universitatsklinikum Madgeburg A.o.R. | Principal Investigator |
| Paul Kim, MD | The Ottawa Hospital | Principal Investigator |
| Amit Atrey, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85234 | United States | ||
| Arizona Institute for Bone and Joint Disorders |
Of the 390 hips/367 participants enrolled there were 36 hips/34 participants censored due to not having the study device, surgery canceled or an inclusion exclusion violation so 354 hips/333 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.
There were 390 hips in 367 participants that were enrolled in the study. (23 bilateral cases).
| ID | Title | Description |
|---|---|---|
| FG000 | Restoration ADM X3 Device | Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 15, 2020 |
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| pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional. |
| All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System | Revision or removal of any study component. | 10 years |
| Patient Satisfaction and Pain: Follow-up Questionnaire | This questionnaire will be used to obtain the following information:
| 6-10 years |
| Radiographic Stability Rates | Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points. | 6 week,1, 2, 3, 4, 5 years |
| Complication Rates for Psoas Impingement and Associated Groin Pain | Reported occurrence of any participant/hip experiencing groin pain or psoas impingement. | 10 years |
| Short Form-12 (SF-12) Improvement From Preoperative Score | 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. | preop, 6 week, 1,2,3,4,5 years |
| Lower Extremity Activity Scale (LEAS) Improvement From Preoperative 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. | preop, 6 week, 1,2,3,4,5 years |
| EQ-5D Index Score Improvement From Preoperative Score | The 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. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health, and a high score shows better health. | preop, 6 week, 1,2,3,4,5 years |
| Percentage of Cases Which Did Not Have Any Component Revised | The number of hips that did not undergo a removal/revision of any of the hip components. | 10 years |
| Brett Greenky, MD |
| Syracuse Orthopedic Specialists |
| Principal Investigator |
| Ajay Aggarwal, MD | Missouri Orthopaedic Institute | Principal Investigator |
| Edward Petrow, DO | Tucson Orthopaedic Institute | Principal Investigator |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Covenant Medical Center | Saginaw | Michigan | 48602 | United States |
| St. Cloud Orthopedic Associates | Sartell | Minnesota | 56377 | United States |
| Missouri Orthopaedic Institute | Columbia | Missouri | 65212 | United States |
| Syracuse Orthopedic Specialists | Fayetteville | New York | 13066 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| The Ottawa Hospital | Ottawa | Ontario | K1H8L6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8 | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Met Protocol Inclusion Criteria |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis population includes 333 participants and 354 hips.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restoration ADM X3 Device | Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For bilateral total hip replacement participants, the age at the time of initial hip replacement surgery is used. | Mean | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Success Rate | Defined as absence of postoperative femoral head dislocation. | Participants/hips with available data up to 10 years or at the time of early study termination. | Posted | Number | hips | 10 years postoperative | hips | hips |
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| Secondary | Harris Hip Score (HHS) Score Improvement From Preoperative 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 | Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional. | Posted | Mean | Standard Deviation | score on a scale | pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional. | hips | hips |
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| Secondary | All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System | Revision or removal of any study component. | Includes all participants who received the study device and were not censored from analysis. | Posted | Number | hips | 10 years | hips | hips |
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| Secondary | Patient Satisfaction and Pain: Follow-up Questionnaire | This questionnaire will be used to obtain the following information:
| Participants/hips with available data at the 6,7,8.9.10 years postoperative. | Posted | Count of Units | hips | 6-10 years | hips | hips |
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| Secondary | Radiographic Stability Rates | Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points. | Participants/hips with available radiographic data submitted at the outcome measure time frames. | Posted | Number | hips | 6 week,1, 2, 3, 4, 5 years | hips | hips |
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| Secondary | Complication Rates for Psoas Impingement and Associated Groin Pain | Reported occurrence of any participant/hip experiencing groin pain or psoas impingement. | Participants/hips that reported an event of groin pain or psoas impingement up until early study termination. | Posted | Number | hips | 10 years | hips | hips |
|
| |||||||||||||||||||||||||||
| Secondary | Short Form-12 (SF-12) Improvement From Preoperative Score | 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. | Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional. | Posted | Mean | Standard Deviation | score on a scale | preop, 6 week, 1,2,3,4,5 years | hips | hips |
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| Secondary | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative 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. | Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional. | Posted | Mean | Standard Deviation | score on a scale | preop, 6 week, 1,2,3,4,5 years | hips | hips |
|
| ||||||||||||||||||||||||||
| Secondary | EQ-5D Index Score Improvement From Preoperative Score | The 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. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health, and a high score shows better health. | Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional. | Posted | Mean | Standard Deviation | score on a scale | preop, 6 week, 1,2,3,4,5 years | hips | hips |
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| Secondary | Percentage of Cases Which Did Not Have Any Component Revised | The number of hips that did not undergo a removal/revision of any of the hip components. | Participants/hips with available data at 10 years or at the time of early study termination. There were 12 hip revisions of the 354 hips in the study, leaving 342 hip cases without a revision of any components. | Posted | Number | hips | 10 years | hips | hips |
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The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Any AEs that meet the protocol defined reportable events must be reported from the time of consent through study completion (10 years) or in this case early study termination.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Date of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in 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 | Operative Site Events | All adverse events whether serious or not that occurred within the study population of 354 hips. These events are reported by unit/hip because in the case of bilateral participants (when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately (by hip) for this reason. | 0 | 354 | 15 | 354 | 56 | 354 |
| EG001 | Non Operative Site Events | All serious systemic adverse events that occurred in the study population of 333 participants. | 13 | 333 | 66 | 333 | 0 | 333 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment | Anemia, Leukemia |
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| Non-operative site | Cardiac disorders | MedDRA | Non-systematic Assessment | Bradycardia, Aortic Stenosis, Syncopal Episode, Stemi, Atrial Flutter, Embolism of Left Middle Cerebral Artery, A-fib, Quadruple Bypass Surgery, Paroxysmal Atrial Fibrillation, Tachycardia |
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| Non-operative site | Endocrine disorders | MedDRA | Non-systematic Assessment | Hypothyroidism |
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| Non-operative site | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | Cholecystectomy, Inguinal Hernia, Hiatal Hernia, Bowel Obstruction, Ruptured Intestine |
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| Non-operative site | Hepatobiliary disorders | MedDRA | Non-systematic Assessment | Liver Cirrhosis |
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| Non-operative site | Infections and infestations | MedDRA | Non-systematic Assessment | Sepsis, Abscess, Bacteremia, Pneumonia, Acute COPD Bronchitis |
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| Non-operative site | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | Thoracic Spine Compression Fracture, Wound Hematoma |
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| Operative site | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | Fall Operative Side, Soft Tissue Trauma, Hip Fracture |
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| Non-operative site | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment | Hypernatremia |
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| Operative site | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | Femur Fracture, Hip Pain, Trochanteric Bursitis, Tibial Plateau Fracture, Soft Tissue Trauma, Tendonitis, Muscle Repair, Femoral Component Loosening, Metallosis |
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| Non-operative site | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | Shoulder Impingement, Thoracic Spine Fracture, Spinal Stenosis, Spinal Fusion, |
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| Non-operative site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment | Lung Cancer, Myeloblastoma of the brain, Pancreatic cancer, Prostate cancer, Renal Cancer, Breast Cancer |
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| Operative site | Nervous system disorders | MedDRA | Non-systematic Assessment | Nerve Palsy |
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| Non-operative site | Nervous system disorders | MedDRA | Non-systematic Assessment | Alzheimer's Dementia, Acute Intracerebral Hemorrhage |
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| Non-operative site | Renal and urinary disorders | MedDRA | Non-systematic Assessment | UTI, Chronic Renal Insufficiency, Worsening Renal Function, Kidney Cancer |
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| Non-operative site | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment | Lung Cancer, Pneumonia, Pulmonary Embolism, Difficulty Breathing |
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| Non-operative site | Surgical and medical procedures | MedDRA | Non-systematic Assessment | Ulcus Left Thorax, Trauma |
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| Non-operative site | Vascular disorders | MedDRA | Non-systematic Assessment | DVT, Stroke, Atherosclerosis, Pulmonary Embolism, Coronary Artery Disease |
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| Non-operative site | General disorders | MedDRA | Non-systematic Assessment | Generalized weakness |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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Due to circumstances starting with the COVID-19 pandemic and challenges recalling study subjects for long term postoperative visits, the follow-up compliance decreased significantly. Therefore, there would be inadequate subjects to analyze at the 10 year endpoint. For this reason, a business decision was made to close the study early.
Each study investigator has independent publication privileges for their own center's results after multi-center publications are submitted. Sponsor requires review of publications. Sponsor shall not edit or influence the publications except to ensure that confidential information is not disclosed, no off-label device use is promoted, and that data is accurately represented. Any publications must be submitted to Stryker for review at least 60 days prior to submission of publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Barga, Senior Manager, Clinical Affairs | Stryker Orthopaedics | 201-831-5000 | Kevin.Barga@stryker.com |
| Aug 15, 2024 |
| Prot_SAP_ICF_000.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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