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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | OTHER |
| University of Iowa | OTHER |
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The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized. | |
| Bisphosphonate group | Experimental | In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The endpoint for patient participation will be local recurrence | Local recurrence of giant cell tumor of bone | Followed for 2 years postoperatively for study end points |
| Measure | Description | Time Frame |
|---|---|---|
| MSTS Score | The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research | Followed for 2 years postoperatively for study end points |
| Surgical site infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Gruender, RN | Contact | 314-617-3406 | allison.gruender@health.slu.edu | |
| Marsha Steffen, RN | Contact | 314-617-3410 | marsha.steffen@slucare.ssmhealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Los Angeles | Recruiting | Los Angeles | California | 90404 | United States |
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| Johns Hopkins University | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| The Cleveland Clinic | OTHER |
| Wake Forest University | OTHER |
| University of Kansas | OTHER |
| Indiana University | OTHER |
| University of Oklahoma | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Boston Children's Hospital | OTHER |
| American Academy of Orthopaedic Surgeons | OTHER |
| Massachusetts General Hospital | OTHER |
| All India Institute of Medical Sciences | OTHER |
| University of Washington | OTHER |
| University of California | OTHER |
Randomized controlled trial
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The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below.
| Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. |
| Wound healing | The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns. | Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. |
| Potential bisphosphonate complications related to systemic administration | Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw | Followed for 2 years postoperatively for study end points |
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kansas | Completed | Overland Park | Kansas | 66211 | United States |
| Johns Hopkins University Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Saint Louis University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Wake Forest University | Completed | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Allegheny-Singer Research Institute | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| University of Washington | Completed | Seattle | Washington | 98195 | United States |
| McGill University Health Centre | Completed | Montreal | Quebec | H3G 1A4 | Canada |
| All India Institute of Medical Science | Recruiting | New Delhi | 110029 | India |
|
| ID | Term |
|---|---|
| D018212 | Giant Cell Tumor of Bone |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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