Proximal Femoral MetastasesNCT02164019
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
A study testing long-stem cemented hemiarthroplasty (LSCH), intramedullary nailing (IMN) and questionnaires in people with Proximal Femoral Metastases, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Femoral Metastases
- What is being tested?
- long-stem cemented hemiarthroplasty (LSCH), intramedullary nailing (IMN) and questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2014to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgeon's estimated survival ≥ 1 month
- Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur. The anatomic region of interest is defined by a line drawn from the base of the femoral neck to 5 cm below the base of the lesser trochanter or 2 diaphyseal shaft widths, whichever is greater.
- Patients with an impending fracture who have had bevacizumab are eligible provided there will be a 3-week window between their last infusion and surgery.
- Diagnosis of widespread visceral and/or osseous metastatic disease based on clinical and radiographic evidence. (Patients may continue on study if surgery shows a non-malignant process.)
- All cancer diagnoses, except lymphoma, will be eligible
Who cannot join
- Estimated survival <1 month
- A large soft tissue mass or other disease involving an area outside of the defined pertrochanteric anatomic region described above. (Patients excluded based on intraoperative findings will be replaced on the study.)
- Prior surgical treatment of the area (i.e., revision cases). A biopsy does not constitute prior surgical treatment.
- Radiographic evidence of an intramedullary occlusion by blastic metastases that would necessitate an alternative method of treatment, such as a plate/screw construct.
- Diagnosis of lymphoma
- Age < 18 years
- Patients with advanced hip arthritis on radiographic imaging
- Previous randomization for a contralateral procedure as part of this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Duke University
Durham, North Carolina, 27708
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, 10065
University of Rochester Medical Center
Rochester, New York
SUNY Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of
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.
- Conditions
- Proximal Femoral Metastases
- Being tested
- long-stem cemented hemiarthroplasty (LSCH), intramedullary nailing (IMN), questionnaires
- Keywords
- Pathologic Fractures, hip replacements, 12-287
- Medical subject headings
- Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-stem cemented hemiarthroplasty (LSCH)Procedure or surgery
intramedullary nailing (IMN)Procedure or surgery
questionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: long-stem cemented hemiarthroplasty (LSCH); Behavioral: questionnaires |
| 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. Receives: Procedure: intramedullary nailing (IMN); Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post-op
Secondary outcomes (3)
Pain VAS score
Measured: 12 weeks post-op
Narcotic usage cumulative
Measured: 12 weeks post-op
Timed get up and go test
Measured: 12 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femoral MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Upstate Medical University, Spectrum Health Medical Group, University of Rochester, Mayo Clinic, Walter Reed National Military Medical Center, Duke University, Montefiore Medical Center, Medical University of Graz
- Responsible party
- Sponsor
- Investigators
- John Healey, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164019
- Sponsor's protocol ID
- 12-287
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2014
- Last updated
- 22 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of
- ClinicalTrials.gov ID
- NCT02164019
- Acronym / sponsor ID
- 12-287
- Conditions
- Proximal Femoral Metastases
- Keywords
- Pathologic Fractures, hip replacements, 12-287
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- State University of New York - Upstate Medical University, Spectrum Health Medical Group, University of Rochester, Mayo Clinic, Walter Reed National Military Medical Center, Duke University, Montefiore Medical Center, Medical University of Graz
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long-stem cemented hemiarthroplasty (LSCH) | Active comparator | Procedure: long-stem cemented hemiarthroplasty (LSCH), Behavioral: questionnaires(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 | Procedure: intramedullary nailing (IMN), Behavioral: questionnairesIntramedullary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgeon's estimated survival ≥ 1 month
- Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur. The anatomic region of interest is defined by a line drawn from the base of the femoral neck to 5 cm below the base of the lesser trochanter or 2 diaphyseal shaft widths, whichever is greater.
- Patients with an impending fracture who have had bevacizumab are eligible provided there will be a 3-week window between their last infusion and surgery.
- Diagnosis of widespread visceral and/or osseous metastatic disease based on clinical and radiographic evidence. (Patients may continue on study if surgery shows a non-malignant process.)
- All cancer diagnoses, except lymphoma, will be eligible
Key exclusion criteria (8 listed)
- Estimated survival <1 month
- A large soft tissue mass or other disease involving an area outside of the defined pertrochanteric anatomic region described above. (Patients excluded based on intraoperative findings will be replaced on the study.)
- Prior surgical treatment of the area (i.e., revision cases). A biopsy does not constitute prior surgical treatment.
- Radiographic evidence of an intramedullary occlusion by blastic metastases that would necessitate an alternative method of treatment, such as a plate/screw construct.
- Diagnosis of lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long-stem cemented hemiarthroplasty (LSCH) | Procedure or surgery | long-stem cemented hemiarthroplasty (LSCH) |
| intramedullary nailing (IMN) | Procedure or surgery | intramedullary nailing (IMN) |
| questionnaires | Behavioural | intramedullary nailing (IMN), long-stem cemented hemiarthroplasty (LSCH) |
Primary outcome
Toronto Extremity Salvage Score (TESS)
Time frame: 12 weeks post-op
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.
3 secondary outcomes
Pain VAS score
Time frame: 12 weeks post-op
Narcotic usage cumulative
Time frame: 12 weeks post-op
Timed get up and go test
Time frame: 12 weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Metastatic Bone Disease
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Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur
Bone Metastases
Not yet recruiting
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Healey, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long-stem cemented hemiarthroplasty (LSCH), intramedullary nailing (IMN) and questionnaires in people with Proximal Femoral Metastases, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Extremity Salvage Score (TESS) (time frame: 12 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.