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| Name | Class |
|---|---|
| State University of New York - Upstate Medical University | OTHER |
| Spectrum Health Medical Group | UNKNOWN |
| University of Rochester | OTHER |
| Mayo Clinic |
The purpose of this study is to look at two different types of surgeries regularly used for treating cancer that has spread to and weakened the thigh bone (femur). Because it is not known which of these surgeries is best, the investigators will compare the results of the two procedures. They are looking to see if differences exist (after surgery) in function, quality of life, pain control, and possible complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long-stem cemented hemiarthroplasty (LSCH) | Active Comparator | (LSCH), "Hip, Ball, Rod and Cement" Replace the ball of the hip joint with a metal ball and a rod that is placed inside the thigh bone with cement to keep the implant in place. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary. |
|
| intramedullary nailing (IMN) | Active Comparator | Intramedullary nailing (IMN), "Rod and Screws" A metal rod is placed inside your thigh bone and secured in place by metal screws just below the hip and above the knee. The study participation period for each patient is 360 days from the date of surgery and includes 5 defined timepoints that include the suture removal visit at 3 weeks and follow-up clinical visits for radiographs and rehabilitation progress checks at 6 weeks, 12 weeks, 6 months, and 12 months after surgery. At each follow-up visit, a combination of questionnaires and physical tests will be administered to assess physical function, general health status, disability level, and pain control. Some patients may be in a rehabilitation center or on hospice care and will miss their follow-up appointments. To collect data for the primary endpoint, the 6 week and/or 12 week TESS can be done over phone if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long-stem cemented hemiarthroplasty (LSCH) | Procedure |
| ||
| intramedullary nailing (IMN) |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Extremity Salvage Score (TESS) | Implant-specific differences in postoperative functional outcomes will be determined throughout the study period using Toronto Extremity Salvage Score (TESS); the primary outcome assessment will take place at the 12-week follow-up visit. | 12 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS score | 12 weeks post-op | |
| Narcotic usage cumulative | 12 weeks post-op | |
| Timed get up and go test |
| Measure | Description | Time Frame |
|---|---|---|
| Infections | 12 weeks post-op | |
| Blood loss | 12 weeks post-op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Healey, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Medical Group | Grand Rapids | Michigan | 49503 | United States | ||
| Memorial Sloan Kettering Cancer Center 1275 York Avenue |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| Walter Reed National Military Medical Center | FED |
| Duke University | OTHER |
| Montefiore Medical Center | OTHER |
| Medical University of Graz | OTHER |
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| Procedure |
|
| questionnaires | Behavioral |
|
| 12 weeks post-op |
| New York |
| New York |
| 10065 |
| United States |
| University of Rochester Medical Center | Rochester | New York | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| ID | Term |
|---|---|
| D005598 | Fractures, Spontaneous |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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