Clinical trial NCT06918860: Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur
Official title: Complications, Implant Survival and Functional Results After Surgical Treatment of Bone Metastases of Proximal Femur With Intramedullary Nail or Prosthetic Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Metastases
Keywords: bone metastases
proximal femur
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.

Brief summary: The investigators will collect data of patients treated surgically for impending or pathological fracture of the proximal femur due to bone metastases between 01/01/2000 and 31/12/2023 with IMN or THA or HHA or MegaTHA or Mega.

After pre-screening the databases of the respective sites, the investigators expect to find approximately a total of 600 patients. A review will be made from the medical records, radiological imaging, and histological data of partecipants.


Eligibility criteria: Inclusion Criteria:

* Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.
* Age ≥18 y (at the time of surgery)
* Patients with impending or pathological fracture due to bone metastases of the proximal femur (head/neck, intertrochanteric, subtrochanteric area).
* Patients who underwent either IMN or THA or HHA or Mega or MegaTHA.
* Patients with available clinical and imaging data.

Exclusion Criteria:

* Patients with pathological or impending fracture of proximal femur due to primary bone tumor.

Primary outcomes:
measure: Analysis of implant survival
timeFrame: through study completion, an average of 1 year
measure: Analysis of complications
timeFrame: At baseline ( T0)
measure: Analysis of functional score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs Istituto Ortopedico Rizzoli
state: Emilia-Romagna
Study officials:
References:
citation: Wedin R, Bauer HC. Surgical treatment of skeletal metastatic lesions of the proximal femur: endoprosthesis or reconstruction nail? J Bone Joint Surg Br. 2005 Dec;87(12):1653-7. doi: 10.1302/0301-620X.87B12.16629.
citation: Errani C, Mavrogenis AF, Cevolani L, Spinelli S, Piccioli A, Maccauro G, Baldini N, Donati D. Treatment for long bone metastases based on a systematic literature review. Eur J Orthop Surg Traumatol. 2017 Feb;27(2):205-211. doi: 10.1007/s00590-016-1857-9. Epub 2016 Sep 20.
citation: Araki N, Chuman H, Matsunobu T, Tanaka K, Katagiri H, Kunisada T, Hiruma T, Hiraga H, Morioka H, Hatano H, Asanuma K, Nishida Y, Hiraoka K, Okamoto T, Abe S, Watanuki M, Morii T, Sugiura H, Yoshida Y, Ohno T, Outani H, Yokoyama K, Shimose S, Fukuda H, Iwamoto Y. Factors associated with the decision of operative procedure for proximal femoral bone metastasis: Questionnaire survey to institutions participating the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group. J Orthop Sci. 2017 Sep;22(5):938-945. doi: 10.1016/j.jos.2017.05.012. Epub 2017 Jun 17.