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As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support.
Termination is not related to any safety concerns with the products.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Other | Tritanium® Primary Acetabular Shell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanium® Primary Acetabular Shell | Device | Tritanium® Primary Acetabular Shell in total hip replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Intraoperative |
| Harris Hip Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Kopko, MD | Syracuse Orthopedic Specialists, P.C. | Principal Investigator |
| John Noble, MD | Center for Orthopaedics and Spine, LLP | Principal Investigator |
| Carmen Crofoot, MD | Northern Light Eastern Maine Medical Center | Principal Investigator |
| John Diana, MD | Adventist Health St. Helena | Principal Investigator |
| Stephen Duncan, MD | University of Kentucky Research Foundation | Principal Investigator |
| Brock Lindsey, MD | West Virginia University | Principal Investigator |
| Stephen Raterman, MD | Florida Medical Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adventist Health St. Helena | St. Helena | California | 94574 | United States | ||
| Florida Medical Clinic |
275 participants/284 hip cases were enrolled. There were 266 unilateral hip cases and 9 bilateral hips cases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tritanium® Primary Acetabular Shell | Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
275 participants were enrolled making up 284 hip cases. Of the 284 hips, 43 cases were censored and not included in the data analyses. Therefore, 241 cases were included in the analyses.
Of the 284 cases/234 participants, 42 cases completed the study per protocol. 40 participants made up these 42 cases.
| ID | Title | Description |
|---|---|---|
| BG000 | Tritanium® Primary Acetabular Shell | Tritanium® Primary Acetabular Shell Tritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For bilateral total knee replacement participants, the age at the time of initial knee replacement surgery is used. |
| 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 | 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. | Posted | Count of Units | hips | 5 years | hips | hips |
|
Participants were assessed up to 10 years.
Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this 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 Adverse Event(s) | Operative site adverse events are reported by study hip because in the case of bilateral participants (participants who have the study device implanted in both hips), an event can occur in one hip, both hips or the same hip, but at different times and are counted as separate events for this reason. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Deep Joint Infection; Superficial Wound Infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Tendonitis; Bursitis; Hip Pain; Soft Tissue Trauma; Groin Pain: Neuritis; Acetabular Component Loosening; Femoral Crack fracture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Filesha Haniff / Clinical Study Manager | Stryker - Joint Replacement | 1 470.528.9214 | filesha.haniff@stryker.com |
Not provided
| 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 | Aug 24, 2020 | Jun 8, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 |
| 1, 3, and 5 years |
| 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. | 1, 3, and 5 years |
| 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. | 1, 3, and 5 years |
| 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. | 1,2,3,4, and 5 years |
| 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:
| 6, 7, 8, 9, and 10 years |
| 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. | 6 weeks, 1, 3, 5 years |
| Tampa |
| Florida |
| 33542 |
| United States |
| University of Kentucky Research Foundation | Lexington | Kentucky | 40536 | United States |
| Center for Orthopaedics and Spine, LLP | Lake Charles | Louisiana | 70601 | United States |
| Northern Light Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Syracuse Orthopedic Specialists, P.C. | Syracuse | New York | 13214 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Death |
|
| Sponsored Terminated Study |
|
| Cases terminated due to investigator leaving the site and site closure. |
|
| Investigator site closed |
|
| Revision |
|
| Physician Decision |
|
| hips |
|
| Mean |
| Full Range |
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | Cases | hips |
|
| Units | Counts |
|---|
| Participants |
|
| hips |
|
|
| 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). | Bone screws used. | Posted | Count of Units | Hips | Intraoperative | Hips | 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 | A calculable HHS score is a case where all data points are present to calculate the stated score. | Posted | Mean | Standard Deviation | Score on a scale | 1, 3, and 5 years | Hips | 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. | An evaluable case is one where all data points are present to calculate the stated score. | Posted | Mean | Standard Deviation | Score on a scale | 1, 3, and 5 years | Hips | Hips |
|
|
|
| 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. | An evaluable case is one where all data points are present to calculate the stated score. | Posted | Mean | Standard Deviation | Score on a scale | 1, 3, and 5 years | Hips | 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. | A calculable case is one where all data points are present to calculate the stated score. | Posted | Mean | Standard Deviation | Score on a scale | 1,2,3,4, and 5 years | Hips | Hips |
|
|
|
| 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:
| Not all participants completed the Follow-Up Questionnaire at the respective timepoints. | Posted | Count of Units | Hips | 6, 7, 8, 9, and 10 years | Hips | 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. | Frequency of the acetabular shell stability. | Posted | Count of Units | Hips | 6 weeks, 1, 3, 5 years | Hips | Hips |
|
|
|
| 0 |
| 241 |
| 16 |
| 241 |
| 61 |
| 241 |
| EG001 | Non-operative Site Adverse Event(s) | Non-operative site adverse events that were reported by participant. | 13 | 234 | 56 | 234 | 0 | 234 |
|
| Operative Site | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Wound Hematoma |
|
| Operative Site | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Acetabular Component Loosening; Femoral Component Loosening, Hip Pain, Femoral Crack Fracture, Trauma, Tibial Plateau Fracture |
|
| Non-Operative | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Anemia; Hemolytic Anemia |
|
| Non-Operative | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | AV Block; A-FIB; NSTEMI; Abdominal Aortic Aneurysm; Angina / Acute Coronary Syndrome; Unstable Angina Pectoris; HTN; Exacerbation of CHF; CHF; Pacemaker Implant; HTN Crisis; Symptomatic Bradycardia with Hypotension; Vertigo; MI; Microcytic Anemia |
|
| Non-Operative | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | R-Eye Retinal Detachment |
|
| Non-operative | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Ischemic Colitis; Cholecystitis; Mild Postoperative Ileus; Partial SBO; Partial Bowel Obstruction; Small Bowel Obstruction; Acute Colitis and Leukocytosis |
|
| Non-Operative | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Death (cause unspecified); vertigo |
|
| Non-Operative | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Acute Cholecystitis |
|
| Non-Operative | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Pneumonia; Infection; Urinary Tract Infection; Pneumonia, Acute Exacerbation of COPD |
|
| Non-Operative | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Herniated Disk; Tibial & Fibula Fractures, Sprained Muscle; Trauma; Lumbar Pain; Hip OA; Spinal Stenosis; Scoliosis; Herniated Nucleus Pulposus; Spondylosis; Knee OA; Lumbar/Lateral Recess Stenosis; MVC, Polytrauma; Rib Fractures; Subscap Hematoma |
|
| Non-Operative | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Breast; Colon; Osteosarcoma and Metastatic Osteosarcoma; Sarcoma; Leiomyosarcoma; Squamous Cell, Prostate; GI malignancy; Pituitary Adenoma |
|
| Non-Operative | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Neuropathy; Lower Extremity Weakness; Altered Mental Status; Headaches; Aneurysm; Disorientation and Memory Loss; Idiopathic Tremor; Encephalopathy, Cognitive Decline |
|
| Non-operative | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Alcoholism |
|
| Non-Operative | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | COPD; Exacerbation of COPD; Anaphylactic Shock (Insect Sting); Choked |
|
| Non-Operative | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Evacuation of hematoma and removal of extruded herniated nucleus pulposus and endplate cartilage. |
|
| Non-Operative | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | DVT; Pulmonary Embolism; Cerebrovascular Accident, Stroke, Aneurysm |
|
| Non-Operative | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Urinary tract infection |
|
| Operative | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Femoral osteosarcoma |
|
|
There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 30 days to review material intended for publications in order to redact any Confidential Information or Inventions therefrom.
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 3-Year Harris Hip Score |
|
|
| 5-Year Harris Hip Score |
|
|
| 1-Year Mental Component Score |
|
|
| 3-Year Physical Component Score |
|
|
| 3-Year Mental Component Score |
|
|
| 5-Year Physical Component Score |
|
|
| 5-Year Mental Component Score |
|
|
| 3-Year LEAS |
|
|
| 5-Year LEAS |
|
|
| 1-Year EQ5D TTO Valuation Over Time |
|
|
| 2-Year EQ5D Health State Over Time |
|
|
| 2-Year EQ5D TTO Valuation Over Time |
|
|
| 3-Year EQ5D Health State Over Time |
|
|
| 3-Year EQ5D TTO Valuation Over Time |
|
|
| 4-Year EQ5D Health State Over Time |
|
|
| 4-Year EQ5D TTO Valuation Over Time |
|
|
| 5-Year EQ5D Health State Over Time |
|
|
| 5-Year EQ5D TTO Valuation Over Time |
|
|
| 6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO |
|
|
| 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES |
|
|
| 6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO |
|
|
| 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES |
|
|
| 6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO |
|
|
| 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES |
|
|
| 7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO |
|
|
| 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES |
|
|
| 7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO |
|
|
| 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES |
|
|
| 7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO |
|
|
| 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES |
|
|
| 8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO |
|
|
| 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES |
|
|
| 8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO |
|
|
| 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES |
|
|
| 8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO |
|
|
| 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES |
|
|
| 9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO |
|
|
| 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES |
|
|
| 9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO |
|
|
| 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES |
|
|
| 9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO |
|
|
| 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES |
|
|
| 10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO |
|
|
| 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES |
|
|
| 10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO |
|
|
| 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES |
|
|
| 10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO |
|
|
| 6- Weeks Postoperative: Fibrous Stable |
|
|
| 6- Weeks Postoperative: Unstable |
|
|
| 1-Year Postoperative: Stable |
|
|
| 1-Year Postoperative: Fibrous Stable |
|
|
| 1-Year Postoperative: Unstable |
|
|
| 3-Years Postoperative: Stable |
|
|
| 3-Years Postoperative: Fibrous Stable |
|
|
| 3-Years Postoperative: Unstable |
|
|
| 5-Years Postoperative: Stable |
|
|
| 5-Years Postoperative: Fibrous Stable |
|
|
| 5-Years Postoperative: Unstable |
|
|