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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the two year post-operative interval, as measured radiographically in zones 1 and 7.
Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery.
Bilateral DXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 6, 12, and 24 months post-operatively.
Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast.
The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the SF-36 Item Health Survey, WOMAC and UCLA activity scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium Shell with CORAIL stem | Experimental | Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. |
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| Modular Titanium Femoral Stem (Tri-Lock) | Active Comparator | Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip replacement with titanium shell and CORAIL stem | Device | Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density | To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease. | 2 Years Post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Bone Turnover Markers Between Groups | Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative. | 2 Years post-operative |
| Implant Migration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul E Beaulé, MD, FRCSC | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33079901 | Result | Slullitel PA, Mahatma MM, Farzi M, Grammatopoulos G, Wilkinson JM, Beaule PE. Influence of Femoral Component Design on Proximal Femoral Bone Mass After Total Hip Replacement: A Randomized Controlled Trial. J Bone Joint Surg Am. 2021 Jan 6;103(1):74-83. doi: 10.2106/JBJS.20.00351. | |
| 34649747 | Derived | Fischman D, Mahatma MM, Slullitel P, Farzi M, Grammatopoulos G, Poitras S, Wilkinson JM, Beaule PE. Does a Monoblock Acetabular Component With a Ceramic Liner Cause More Pelvic Bone Loss Than a Conventional Modular Cementless Acetabular Component? A 2-Year Randomized Clinical Trial. J Arthroplasty. 2022 Jan;37(1):75-82. doi: 10.1016/j.arth.2021.08.033. Epub 2021 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corail | Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion). |
| 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2013 |
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| Total hip replacement with Modular Titanium Femoral Stem | Device | Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert). |
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Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative.
| 2 years post-operative |
| Change in Modified Harris Hip Score | The change from baseline to 2-years post-operative on the Modified Harris Hip Score (mHHS). The mHHS assesses a patient's functional outcome and pain. The maximum score is 100 and the lowest is 0. A higher score is indicative of better outcomes and lower pain levels. | 2 Years post-operative |
| Change in SF-36 Score | The change from baseline to 2-years post-operative on the SF-36 score: a quality of-life measure. The score consists of 36 questions separated into 8 concepts. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100. The health related quality of life is increases as the scores are increased. The average score is 50. | 2 Years post-operative |
| Change in WOMAC Questionnaire | The change from baseline to 2-years post-operative on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score consists of 24 items, separated into 3 subscales. Each question is scored on a scale of 0 to 4, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The scores of each subscale are summed to give a total score. Higher scores are indicative of worse pain, stiffness and functional limitations. | 2 Years post-operative |
| Change in UCLA Activity Scale | The change from baseline to 2-years post-operative on the UCLA Activity score. The UCLA activity scale is a 10 point scale evaluating a patients activity level. The possible score range is from 0-10. A low value is indicative of sedentary or inactivity, whereas a high score is indicative of high levels of activity. | 2 Years post-operatively |
| FG001 | Tri-Lock | Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Corail | Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion). |
| BG001 | Tri-Lock | Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert). |
| BG002 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| American Society of Anesthesiologists (ASA) Grade | The ASA grade is a physical status classification system that is used for assessing the fitness and co-morbidities of patients before surgery. Patients are categorized between grades 1-6, with a lower grade indicative of better health and less co-morbidities. | 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 | Change in Bone Mineral Density | To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease. | Posted | Mean | Standard Deviation | number of pixels with change | 2 Years Post-operative |
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| Secondary | Comparison of Bone Turnover Markers Between Groups | Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative. | Not Posted | 2 Years post-operative | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Implant Migration | Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative. | Not Posted | 2 years post-operative | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Modified Harris Hip Score | The change from baseline to 2-years post-operative on the Modified Harris Hip Score (mHHS). The mHHS assesses a patient's functional outcome and pain. The maximum score is 100 and the lowest is 0. A higher score is indicative of better outcomes and lower pain levels. | Not Posted | 2 Years post-operative | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in SF-36 Score | The change from baseline to 2-years post-operative on the SF-36 score: a quality of-life measure. The score consists of 36 questions separated into 8 concepts. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100. The health related quality of life is increases as the scores are increased. The average score is 50. | Not Posted | 2 Years post-operative | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in WOMAC Questionnaire | The change from baseline to 2-years post-operative on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score consists of 24 items, separated into 3 subscales. Each question is scored on a scale of 0 to 4, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The scores of each subscale are summed to give a total score. Higher scores are indicative of worse pain, stiffness and functional limitations. | Not Posted | 2 Years post-operative | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in UCLA Activity Scale | The change from baseline to 2-years post-operative on the UCLA Activity score. The UCLA activity scale is a 10 point scale evaluating a patients activity level. The possible score range is from 0-10. A low value is indicative of sedentary or inactivity, whereas a high score is indicative of high levels of activity. | Not Posted | 2 Years post-operatively | Participants |
Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).
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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 | Corail | Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion). | 0 | 40 | 1 | 40 | 4 | 40 |
| EG001 | Tri-Lock | Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert). | 0 | 46 | 1 | 46 | 7 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial wound infection | Infections and infestations | Non-systematic Assessment | Superficial wound infection 1 month post-op requiring irrigation and debridement (I&D) surgery. |
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| Aseptic Loosening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Aseptic loosening is considered a relatively common complication of hip joint replacements. The patient generally experiences a great deal of pain and requires revision surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thigh pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participants that reported greater than normal pain levels in the thigh area. |
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| Intra-operative Calcar Fracture | Metabolism and nutrition disorders | Non-systematic Assessment | The incidence of intraoperative calcar fractures, a known complication of total hip arthroplasty (THA). |
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| Femoral nerve palsy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Femoral nerve dysfunction is a loss of movement or sensation in parts of the legs due to damage to the femoral nerve and is a complication that occurs during surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Beaule | The Ottawa Hospital Research Institute | 613-737-8899 | 73265 | pbeaule@toh.ca |
| Nov 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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