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RecruitingNCT06918860Updated May 22, 2026

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

An observational study in Bone Metastases, sponsored by Costantino Errani. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Costantino Errani · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bone Metastases

Keywords

  • bone metastases
  • proximal femur
03

In context

Lead sponsor

Costantino Errani is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients with pathological or impending fracture of proximal femur due to primary bone tumor.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherAnalysis

    Analysis and review of imaging and clinical data

06

What researchers measure

Primary outcomes

  1. Analysis of implant survival

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

    Time frame: through study completion, an average of 1 year

  2. Analysis of complications

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

    Time frame: At baseline ( T0)

  3. Analysis of functional score

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 16326880 ↗
  • 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. PubMed 27650452 ↗
  • 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. PubMed 28629828 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06918860
Lead sponsor
Costantino Errani
Responsible party
Costantino Errani (Principal Investigator, Istituto Ortopedico Rizzoli) — Sponsor-investigator
First posted
Apr 9, 2025
Start date
May 30, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 22, 2026

Study contacts

Costantino Errani, MD
Contact
costantino.errani@ior.it
0516366 ext. Ext. 103
Roberta Laranga, PhD
Contact
roberta.laranga@ior.it
0516366 ext. Ext. 5123

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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