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Metastatic Pathologic Fractures, Short Term Results

Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05825456
Enrollment
200
Registered
2023-04-24
Start date
2022-01-01
Completion date
2026-01-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathologic Fracture, Bone Metastases, Metastatic Cancer

Keywords

bone metastasis, pathologic fracture, endoprosthetic reconstruction, intramedullary nailing, open reduction internal fixation, plate and screws

Brief 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.

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.

Interventions

PROCEDUREendoprosthetic reconstruction

This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.

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.

PROCEDUREOpen reduction internal fixation with plate and screws

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.

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* metastatic pathologic fracture * operated via endoprosthesis, intramedullary nail or plate & screws

Exclusion criteria

* primary bone tumor * conservative management * neuromuscular disease * periprosthetic fractures * less than 1 month follow up

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)PreoperativeWOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Musculoskeletal Tumor Society (MSTS) scorePreoperativeMSTS 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)PreoperativeTESS 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)PreoperativeVAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Upper Extremity Functional Scale (UEFS)PreoperativeUEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH)PreoperativeDASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)PreoperativeLEFS is a functional scale for lower extremity. It is not specific for tumor patients.

Secondary

MeasureTime frameDescription
Survivalup to 3 monthsTime that the patient lives after the surgery
Days at hospital after surgeryup to 1 monthHospitalization length required after the surgery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026