Bone Metastases of a Malignant TumorPHM-HANCT07471022
Hemiarthroplasty for Elderly With Proximal Humeral Mets
An observational study of Bone Metastases of a Malignant Tumor and Metastatic Bone Tumor, run by Sichuan Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Metastases of a Malignant Tumor, Metastatic Bone Tumor
- What is being tested?
- Proximal Humeral Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 4 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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..
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- Proximal Humeral Hemiarthroplasty
- Keywords
- Proximal Humeral Metastases, Bone Metastases, Hemiarthroplasty, Shoulder Arthroplasty, Elderly Patients
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Humeral HemiarthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Patients (≥65 Years) | Patients aged 65 years or older with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution. Receives: 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. Receives: Procedure: Proximal Humeral Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
(ASES) Score
Shoulder Function Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Measured: Postoperative follow-up (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jan 2013
- Primary completion31 Dec 2021
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Metastases of a Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingbo Zhao, Sichuan Provincial People's Hospital
- Investigators
- Ji Zhou, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471022
- Sponsor's protocol ID
- 2025-522
- Acronym
- PHM-HA
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Hemiarthroplasty in Elderly Patients With Proximal Humeral Metastases
- ClinicalTrials.gov ID
- NCT07471022
- Acronym / sponsor ID
- PHM-HA / 2025-522
- Keywords
- Proximal Humeral Metastases, Bone Metastases, Hemiarthroplasty, Shoulder Arthroplasty, Elderly Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly Patients (≥65 Years) | – | Procedure: Proximal Humeral HemiarthroplastyPatients aged 65 years or older with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution. |
| Younger Patients (<65 Years) | – | Procedure: Proximal Humeral HemiarthroplastyPatients younger than 65 years with solitary proximal humeral metastases who underwent proximal humeral hemiarthroplasty at our institution. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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..
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal Humeral HemiarthroplastyPatients 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. | Procedure or surgery | Elderly Patients (≥65 Years), Younger Patients (<65 Years) |
Primary outcome
(ASES) Score
Time frame: Postoperative follow-up (up to 24 months)
Shoulder Function Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Zhou study chair
Sichuan Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases of a Malignant Tumor and Metastatic Bone Tumor, run by Sichuan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(ASES) Score (time frame: Postoperative follow-up (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.