Pathologic FractureNCT05825456
Metastatic Pathologic Fractures, Short Term Results
An observational study of Pathologic Fracture and Bone Metastases, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathologic Fracture, Bone Metastases, Metastatic Cancer
- What is being tested?
- endoprosthetic reconstruction, Intramedullary nailing and Open reduction internal fixation with plate and screws
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate \& screws.
Who may be able to join
- metastatic pathologic fracture
- operated via endoprosthesis, intramedullary nail or plate \& screws
Who cannot join
- primary bone tumor
- conservative management
- neuromuscular disease
- periprosthetic fractures
- less than 1 month follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Medical Faculty
Ankara, altindag, 06230
Merve Dursun Savran, MD, 00905395571557, merve8dursun@gmail.com
Mustafa Onur Karaca, Assc. Proff, 00905324812113, karaca_onur@yahoo.com
About this study
Official title: Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation
This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.
Read the detailed description
The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.
Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.
The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.
The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.
The type of the operation will be decided at the multidisciplinary tumor council of ankara University.
- Conditions
- Pathologic Fracture, Bone Metastases, Metastatic Cancer
- Being tested
- endoprosthetic reconstruction, Intramedullary nailing, Open reduction internal fixation with plate and screws
- Keywords
- bone metastasis, pathologic fracture, endoprosthetic reconstruction, intramedullary nailing, open reduction internal fixation, plate and screws
- Medical subject headings
- Fractures, Spontaneous, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoprosthetic reconstructionProcedure or surgery
This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.
Intramedullary nailingProcedure or surgery
This is a type of surgery in which the affected bone is stabilized by a nail. The affected part could be removed or retained. If removed, the defect is filled with bone cement.
Open reduction internal fixation with plate and screwsProcedure or surgery
This is a type of surgery in which the affected part of the bone is visualized completely, after the reduction is achieved, the fixation is provided with appropriate plates and screws. Again the affected part could be removed or retained. If removed, the defect is filled with bone cement.
| Study group | Role | What they receive |
|---|---|---|
| endoprosthetic reconstruction | This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures. Receives: Procedure: endoprosthetic reconstruction | |
| intramedullary nail | This is the group of patients with metastatic pathologic fractures treated with intramedullary nail, and additional bone cement if needed. For example, proximal femur nail for trochanteric fractures, or long femoral nail for femoral shaft fractures. Receives: Procedure: Intramedullary nailing | |
| open reduction internal fixation with plate and screws | This is the group of patients with metastatic pathologic fractures treated with open reduction internal fixation; with plates and screws. For example, reconstruction plates for pelvic fractures or 3.5 locking compression plates for humeral or femur shaft fractures. Receives: Procedure: Open reduction internal fixation with plate and screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal Tumor Society (MSTS) score
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Measured: Preoperative
Musculoskeletal Tumor Society (MSTS) score
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Measured: Postoperative 1st day
Musculoskeletal Tumor Society (MSTS) score
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Measured: Postoperative 1st week
Musculoskeletal Tumor Society (MSTS) score
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Measured: Postoperative 1st month
Toronto Extremity Salvage Score (TESS)
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Measured: Preoperative
Toronto Extremity Salvage Score (TESS)
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Measured: Postoperative 1st day
Toronto Extremity Salvage Score (TESS)
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Measured: Postoperative 1st week
Toronto Extremity Salvage Score (TESS)
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Measured: Postoperative 1st month
Visual analog scale (VAS)
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Measured: Preoperative
Visual analog scale (VAS)
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Measured: Postoperative 1st day
Visual analog scale (VAS)
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Measured: Postoperative 1st week
Visual analog scale (VAS)
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Measured: Postoperative 1st month
Upper Extremity Functional Scale (UEFS)
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Measured: Preoperative
Upper Extremity Functional Scale (UEFS)
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st day
Upper Extremity Functional Scale (UEFS)
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st week
Upper Extremity Functional Scale (UEFS)
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st month
Disabilities of Arm, Shoulder and Hand (DASH)
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Measured: Preoperative
Disabilities of Arm, Shoulder and Hand (DASH)
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st day
Disabilities of Arm, Shoulder and Hand (DASH)
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st week
Disabilities of Arm, Shoulder and Hand (DASH)
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Measured: Postoperative 1st month
Lower Extremity Functional Scale (LEFS)
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Measured: Preoperative
Lower Extremity Functional Scale (LEFS)
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st day
Lower Extremity Functional Scale (LEFS)
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st week
Lower Extremity Functional Scale (LEFS)
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Measured: Preoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st day
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st week
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Measured: Postoperative 1st month
Secondary outcomes (2)
Days at hospital after surgery
Hospitalization length required after the surgery.
Measured: up to 1 month
Survival
Time that the patient lives after the surgery
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Dursun Savran, MD, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825456
- Sponsor's protocol ID
- AnkaraUniOrtho
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final MSTS, TESS, UEFS, LEFS, DASH, WOMAC, VAS will be shared when the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation
- ClinicalTrials.gov ID
- NCT05825456
- Acronym / sponsor ID
- AnkaraUniOrtho
- Conditions
- Pathologic Fracture, Bone Metastases, Metastatic Cancer
- Keywords
- bone metastasis, pathologic fracture, endoprosthetic reconstruction, intramedullary nailing, open reduction internal fixation, plate and screws
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 24 Apr 2023 (actual)
- 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.
This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.
Detailed description
The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.
Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.
The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.
The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.
The type of the operation will be decided at the multidisciplinary tumor council of ankara University.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endoprosthetic reconstruction | – | Procedure: endoprosthetic reconstructionThis is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures. |
| intramedullary nail | – | Procedure: Intramedullary nailingThis is the group of patients with metastatic pathologic fractures treated with intramedullary nail, and additional bone cement if needed. For example, proximal femur nail for trochanteric fractures, or long femoral nail for femoral shaft fractures. |
| open reduction internal fixation with plate and screws | – | Procedure: Open reduction internal fixation with plate and screwsThis is the group of patients with metastatic pathologic fractures treated with open reduction internal fixation; with plates and screws. For example, reconstruction plates for pelvic fractures or 3.5 locking compression plates for humeral or femur shaft fractures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate \& screws.
Key inclusion criteria (2 listed)
- metastatic pathologic fracture
- operated via endoprosthesis, intramedullary nail or plate \& screws
Key exclusion criteria (5 listed)
- primary bone tumor
- conservative management
- neuromuscular disease
- periprosthetic fractures
- less than 1 month follow up
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 |
|---|---|---|
| endoprosthetic reconstructionThis is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis. | Procedure or surgery | endoprosthetic reconstruction |
| Intramedullary nailingThis is a type of surgery in which the affected bone is stabilized by a nail. The affected part could be removed or retained. If removed, the defect is filled with bone cement. | Procedure or surgery | intramedullary nail |
| Open reduction internal fixation with plate and screwsThis is a type of surgery in which the affected part of the bone is visualized completely, after the reduction is achieved, the fixation is provided with appropriate plates and screws. Again the affected part could be removed or retained. If removed, the defect is filled with bone cement. | Procedure or surgery | open reduction internal fixation with plate and screws |
Primary outcome
Musculoskeletal Tumor Society (MSTS) score
Time frame: Preoperative
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Musculoskeletal Tumor Society (MSTS) score
Time frame: Postoperative 1st day
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Musculoskeletal Tumor Society (MSTS) score
Time frame: Postoperative 1st week
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Musculoskeletal Tumor Society (MSTS) score
Time frame: Postoperative 1st month
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Toronto Extremity Salvage Score (TESS)
Time frame: Preoperative
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Toronto Extremity Salvage Score (TESS)
Time frame: Postoperative 1st day
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Toronto Extremity Salvage Score (TESS)
Time frame: Postoperative 1st week
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Toronto Extremity Salvage Score (TESS)
Time frame: Postoperative 1st month
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Visual analog scale (VAS)
Time frame: Preoperative
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS)
Time frame: Postoperative 1st day
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS)
Time frame: Postoperative 1st week
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS)
Time frame: Postoperative 1st month
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Upper Extremity Functional Scale (UEFS)
Time frame: Preoperative
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS)
Time frame: Postoperative 1st day
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS)
Time frame: Postoperative 1st week
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS)
Time frame: Postoperative 1st month
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: Preoperative
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: Postoperative 1st day
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: Postoperative 1st week
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH)
Time frame: Postoperative 1st month
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)
Time frame: Preoperative
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)
Time frame: Postoperative 1st day
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)
Time frame: Postoperative 1st week
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)
Time frame: Postoperative 1st month
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Preoperative
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Postoperative 1st day
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Postoperative 1st week
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Postoperative 1st month
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
2 secondary outcomes
Days at hospital after surgery
Time frame: up to 1 month
Survival
Time frame: up to 3 months
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 5 Mar 2025.
- Individual participant dataSharing planned: No. Final MSTS, TESS, UEFS, LEFS, DASH, WOMAC, VAS will be shared when the study is completed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathologic Fracture and Bone Metastases, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal Tumor Society (MSTS) score (time frame: Preoperative). The study lists 28 primary outcomes in all. 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 5 Mar 2025.