Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur

NCT06918860 | Recruiting

• 1 other identifier: BoneMetaProFe
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Keywords

bone metastases; proximal femur

Outcome Measures

Primary Outcomes (3)

• Analysis of implant survival

  Assess the longevity associated with the different surgical treatments used for proximal femur bone metastases.

  through study completion, an average of 1 year

• Analysis of complications

  Assess the post-operative complications associated with the different surgical treatments used for proximal femur bone metastases.

  At baseline ( T0)

• Analysis of functional score

  Assess the functional score associated with the different surgical treatments used for proximal femur bone metastases.

  1 year

Study Arms (1)

Patients

Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.

Other: Analysis

Interventions

Analysis OTHER

Analysis and review of imaging and clinical data

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Costantino Errani: lead

Study Sites (1)

Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 16326880 BACKGROUND

• 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.

  PMID: 27650452 BACKGROUND

• 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.

  PMID: 28629828 BACKGROUND

Central Study Contacts

Costantino Errani, MD

CONTACT

0516366; costantino.errani@ior.it

Roberta Laranga, PhD

CONTACT

0516366; roberta.laranga@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: May 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

IT (1)