NCT07471022

Brief Summary

Bone metastases are common in patients with advanced cancer and frequently involve the proximal humerus, leading to severe pain and loss of shoulder function. Shoulder arthroplasty is an important surgical option for restoring limb function and relieving pain in these patients. However, elderly patients often have multiple comorbidities, and it remains unclear whether age affects surgical outcomes and prognosis after arthroplasty for proximal humeral metastases. This retrospective observational study reviewed patients with isolated proximal humeral metastases who underwent shoulder arthroplasty at our institution. Patients were divided into elderly and younger groups based on age, and clinical outcomes were compared between the groups. Evaluated outcomes included operative characteristics, postoperative pain, limb function, complications, survival, recurrence, and quality of life. The aim of this study is to determine whether age influences prognosis and functional recovery after shoulder arthroplasty for proximal humeral metastases, and to assess the feasibility and effectiveness of this surgical procedure in elderly patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

Proximal Humeral MetastasesBone MetastasesHemiarthroplastyShoulder ArthroplastyElderly Patients

Outcome Measures

Primary Outcomes (1)

  • (ASES) Score

    Shoulder Function Assessed by the American Shoulder and Elbow Surgeons (ASES) Score

    Postoperative follow-up (up to 24 months)

Study Arms (2)

Elderly Patients (≥65 Years)

Patients aged 65 years or older with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution.

Procedure: Proximal Humeral Hemiarthroplasty

Younger Patients (<65 Years)

Patients younger than 65 years with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution.

Procedure: Proximal Humeral Hemiarthroplasty

Interventions

Patients underwent wide tumor excision followed by proximal humeral hemiarthroplasty. En bloc resection was performed according to tumor-free principles, with preservation of the axillary nerve and deltoid muscle whenever possible. Osteotomy was performed 2-3 cm distal to the tumor margin. A tumor-specific prosthesis was implanted and soft tissues were reconstructed. A Ligament Advanced Reinforcement System (LARS) was used when necessary to improve joint stability.

Elderly Patients (≥65 Years)Younger Patients (<65 Years)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included adult patients with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution between 2013 and 2021. Both male and female patients were eligible. Patients were divided into two groups based on age (≥65 years and \<65 years) to compare surgical outcomes, functional recovery, complications, and survival. All patients had confirmed metastatic bone tumors, with lesions localized to the proximal humerus and without involvement of the scapula or axillary nerve. Patients with multiple bone metastases or severe comorbidities were excluded.

You may qualify if:

  • Patients with a single metastatic lesion in the proximal humerus, confirmed by imaging or biopsy.
  • Presence of pathological fracture or a severe osteolytic lesion at risk of fracture (Mirels score ≥9).
  • Poor response to radiotherapy according to RECIST 1.1 criteria.
  • Persistent severe shoulder pain or significant loss of shoulder function.
  • Estimated life expectancy \>3 months at the time of surgery..

You may not qualify if:

  • Patients with multiple bone metastases involving two or more skeletal sites.
  • Metastatic lesions affecting the scapula, axillary nerve, or brachial plexus.
  • Death during the perioperative period.
  • Presence of three or more significant comorbidities, such as uncontrolled diabetes, severe cardiopulmonary disease, or chronic renal failure.
  • Loss to follow-up within 3 months after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Ji Zhou

    Sichuan Provincial People's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

January 1, 2013

Primary Completion

December 31, 2021

Study Completion

September 4, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient privacy concerns and ethical restrictions. The data include sensitive medical information collected from hospital records, and sharing such data could risk identification of patients.