- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471022
Hemiarthroplasty for Elderly With Proximal Humeral Mets (PHM-HA)
The Application of Hemiarthroplasty in Elderly Patients With Proximal Humeral Metastases
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
This retrospective observational study reviewed patients who underwent proximal humeral hemiarthroplasty (PHH) for solitary metastatic lesions of the proximal humerus at our institution between 2013 and 2021. A total of 53 patients with histopathologically confirmed metastatic bone tumors were included in the analysis. The study population consisted of 25 males and 28 females, with ages ranging from 43 to 82 years.
Patients were divided into two groups according to age: Group A (≥65 years, n = 25) and Group B (<65 years, n = 28). All metastatic lesions were unilateral and located in the proximal one-third of the humerus without involvement of the scapula.
The most common primary malignancies included breast cancer, lung cancer, renal cell carcinoma, thyroid cancer, prostate cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, uterine cancer, and cancer of unknown primary origin. Prior resection of the primary tumor had been performed in 22 patients before presentation. Nineteen patients had comorbidities such as diabetes mellitus, hypertension, chronic gastritis, or pulmonary emphysema. Pathological fractures were present in 19 cases.
All patients underwent wide tumor excision followed by proximal humeral hemiarthroplasty using a Malawer type I resection technique. Clinical and surgical data were collected from medical records for subsequent analysis.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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..
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elderly Patients (≥65 Years)
Patients aged 65 years or older with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution.
|
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.
|
|
Younger Patients (<65 Years)
Patients younger than 65 years with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(ASES) Score
Time Frame: Postoperative follow-up (up to 24 months)
|
Shoulder Function Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
|
Postoperative follow-up (up to 24 months)
|
Collaborators and Investigators
Investigators
- Study Chair: Ji Zhou, Sichuan Provincial People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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