Proximal Humerus FractureNCT07769398
Traditional Mongolian Medicine Bone-Setting Versus Surgery for Humeral Surgical Neck Fracture
A study testing Traditional Mongolian Medicine Bone-Setting and Open Reduction and Internal Fixation in people with Proximal Humerus Fracture, run by Mongolian National University of Medical Sciences at 1 site in China.
Trial summary
The goal of this study was to compare Traditional Mongolian Medicine (TMM) bone-setting with open reduction and internal fixation (ORIF) surgery for adults with humeral surgical neck fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humerus Fracture
- What is being tested?
- Traditional Mongolian Medicine Bone-Setting and Open Reduction and Internal Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 31 May 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older,
- Radiographically confirmed humeral surgical neck fracture (Neer 2-part),
- Presentation within 7 days of injury,
- Ability to provide informed consent,
- Willingness to comply with the follow-up schedule,
Who cannot join
- Open fracture,
- Pathological fracture, including fracture due to malignancy or metabolic bone disease,
- Ipsilateral upper-extremity fracture or injury requiring separate treatment,
- Previous fracture or surgery of the affected shoulder,
- Neurovascular injury requiring immediate surgical intervention,
- Cognitive impairment precluding informed consent or outcome assessment,
- Medical contraindication to either treatment modality, including active infection precluding surgery or a skin condition precluding splinting for TMM treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Scientific Research, International Mongolian Medicine Hospital
Hohhot, Inner Mongolia
About this study
Official title: Traditional Mongolian Medicine Bone-Setting Versus Open Reduction and Internal Fixation for Humeral Surgical Neck Fracture: A Prospective Non-Randomized Comparative Cohort Study
The goal of this study was to compare Traditional Mongolian Medicine (TMM) bone-setting with open reduction and internal fixation (ORIF) surgery for adults with humeral surgical neck fracture. The study examined whether the two treatment approaches were associated with different patterns of pain relief and recovery of shoulder function during 6 months of follow-up. Participants received either TMM bone-setting or ORIF surgery. Treatment selection was based on patient preference and clinical judgement rather than random assignment. Researchers assessed pain and shoulder function at 1, 3, and 6 months after treatment using the Visual Analogue Scale for pain and the Constant-Murley shoulder score.
Read the detailed description
This was a prospective, single-center, non-randomized comparative study conducted at the Inner Mongolia International Mongolian Medicine Hospital, Hohhot, Inner Mongolia, China. Sixty adults with radiographically confirmed Neer 2-part humeral surgical neck fracture were included, with 30 receiving Traditional Mongolian Medicine bone-setting and 30 undergoing open reduction and internal fixation surgery. Treatment selection was based on patient preference and clinical judgement. The Traditional Mongolian Medicine bone-setting intervention consisted of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation assessment included evaluation of distal circulation, skin condition, sensation, pain, and swelling, followed by radiographic confirmation of fracture alignment. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was administered as part of the study intervention. The comparator was open reduction and internal fixation using locking plate fixation with postoperative rehabilitation. Participants were followed for 6 months. The study evaluated longitudinal differences in pain and shoulder function between the two treatment groups.
- Conditions
- Proximal Humerus Fracture
- Being tested
- Traditional Mongolian Medicine Bone-Setting, Open Reduction and Internal Fixation
- Keywords
- Humeral Surgical Neck Fracture, Neer 2-Part Fracture, Traditional Mongolian Medicine, Bone-Setting, Open Reduction and Internal Fixation, Shoulder Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Mongolian Medicine Bone-SettingOther
Traditional Mongolian Medicine bone-setting consisted of closed manual reduction of the humeral surgical neck fracture followed by external fixation with wooden splints, pressure pads, and bandage ties. Splint placement and tightness were adjusted according to fracture alignment and the patient's clinical condition. After fixation, distal circulation, skin color and temperature, sensation, swelling, and pain were assessed, and fracture alignment was confirmed radiographically. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was used.
Open Reduction and Internal FixationProcedure or surgery
Open reduction and internal fixation of the humeral surgical neck fracture using a proximal humerus locking plate system under general anesthesia, followed by routine postoperative care and progressive rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Mongolian Medicine Bone-Setting | Experimental | Participants received Traditional Mongolian Medicine bone-setting consisting of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation clinical assessment and radiographic confirmation of fracture alignment were performed. No herbal, botanical, alcohol-based, or other topical medicinal preparation was used. Receives: Other: Traditional Mongolian Medicine Bone-Setting |
| Open Reduction and Internal Fixation | Active comparator | Participants underwent open reduction and internal fixation with proximal humerus locking plate fixation, followed by routine postoperative care and progressive rehabilitation. Receives: Procedure: Open Reduction and Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual Analogue Scale Pain Score
Shoulder pain was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Mean scores were compared between the two treatment groups at each follow-up assessment.
Measured: 1 month, 3 months, and 6 months post-treatment
Mean Constant-Murley Total Score
Shoulder function was assessed using the Constant-Murley score, ranging from 0 to 100 points. The score includes pain (0-15 points), activities of daily living (0-20), active range of motion (0-40), and abduction strength (0-25). Higher total scores indicate better shoulder function. Mean total scores were compared between treatment groups.
Measured: 1 month, 3 months, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Jun 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongolian National University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Inner Mongolia Medical University
- Responsible party
- Principal investigator, Dariimaa Ganbat, Mongolian National University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769398
- Sponsor's protocol ID
- 24-25/10-01
- Other IDs
- 2022YFC3501003
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, privacy, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Mongolian Medicine Bone-Setting Versus Open Reduction and Internal Fixation for Humeral Surgical Neck Fracture: A Prospective Non-Randomized Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07769398
- Acronym / sponsor ID
- 24-25/10-01
- Conditions
- Proximal Humerus Fracture
- Keywords
- Humeral Surgical Neck Fracture, Neer 2-Part Fracture, Traditional Mongolian Medicine, Bone-Setting, Open Reduction and Internal Fixation, Shoulder Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mongolian National University of Medical SciencesUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Inner Mongolia Medical University
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 Aug 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.
The goal of this study was to compare Traditional Mongolian Medicine (TMM) bone-setting with open reduction and internal fixation (ORIF) surgery for adults with humeral surgical neck fracture. The study examined whether the two treatment approaches were associated with different patterns of pain relief and recovery of shoulder function during 6 months of follow-up. Participants received either TMM bone-setting or ORIF surgery. Treatment selection was based on patient preference and clinical judgement rather than random assignment. Researchers assessed pain and shoulder function at 1, 3, and 6 months after treatment using the Visual Analogue Scale for pain and the Constant-Murley shoulder score.
Detailed description
This was a prospective, single-center, non-randomized comparative study conducted at the Inner Mongolia International Mongolian Medicine Hospital, Hohhot, Inner Mongolia, China. Sixty adults with radiographically confirmed Neer 2-part humeral surgical neck fracture were included, with 30 receiving Traditional Mongolian Medicine bone-setting and 30 undergoing open reduction and internal fixation surgery. Treatment selection was based on patient preference and clinical judgement. The Traditional Mongolian Medicine bone-setting intervention consisted of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation assessment included evaluation of distal circulation, skin condition, sensation, pain, and swelling, followed by radiographic confirmation of fracture alignment. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was administered as part of the study intervention. The comparator was open reduction and internal fixation using locking plate fixation with postoperative rehabilitation. Participants were followed for 6 months. The study evaluated longitudinal differences in pain and shoulder function between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Mongolian Medicine Bone-Setting | Experimental | Other: Traditional Mongolian Medicine Bone-SettingParticipants received Traditional Mongolian Medicine bone-setting consisting of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation clinical assessment and radiographic confirmation of fracture alignment were performed. No herbal, botanical, alcohol-based, or other topical medicinal preparation was used. |
| Open Reduction and Internal Fixation | Active comparator | Procedure: Open Reduction and Internal FixationParticipants underwent open reduction and internal fixation with proximal humerus locking plate fixation, followed by routine postoperative care and progressive rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older,
- Radiographically confirmed humeral surgical neck fracture (Neer 2-part),
- Presentation within 7 days of injury,
- Ability to provide informed consent,
- Willingness to comply with the follow-up schedule,
Key exclusion criteria (7 listed)
- Open fracture,
- Pathological fracture, including fracture due to malignancy or metabolic bone disease,
- Ipsilateral upper-extremity fracture or injury requiring separate treatment,
- Previous fracture or surgery of the affected shoulder,
- Neurovascular injury requiring immediate surgical intervention,
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 |
|---|---|---|
| Traditional Mongolian Medicine Bone-SettingTraditional Mongolian Medicine bone-setting consisted of closed manual reduction of the humeral surgical neck fracture followed by external fixation with wooden splints, pressure pads, and bandage ties. Splint placement and tightness were adjusted according to fracture alignment and the patient's clinical condition. After fixation, distal circulation, skin color and temperature, sensation, swelling, and pain were assessed, and fracture alignment was confirmed radiographically. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was used. | Other | Traditional Mongolian Medicine Bone-Setting |
| Open Reduction and Internal FixationOpen reduction and internal fixation of the humeral surgical neck fracture using a proximal humerus locking plate system under general anesthesia, followed by routine postoperative care and progressive rehabilitation. | Procedure or surgery | Open Reduction and Internal Fixation |
Primary outcome
Mean Visual Analogue Scale Pain Score
Time frame: 1 month, 3 months, and 6 months post-treatment
Shoulder pain was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Mean scores were compared between the two treatment groups at each follow-up assessment.
Mean Constant-Murley Total Score
Time frame: 1 month, 3 months, and 6 months post-treatment
Shoulder function was assessed using the Constant-Murley score, ranging from 0 to 100 points. The score includes pain (0-15 points), activities of daily living (0-20), active range of motion (0-40), and abduction strength (0-25). Higher total scores indicate better shoulder function. Mean total scores were compared between treatment groups.
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, privacy, and institutional requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Mongolian Medicine Bone-Setting and Open Reduction and Internal Fixation in people with Proximal Humerus Fracture, run by Mongolian National University of Medical Sciences at 1 site in China.
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 7 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mean Visual Analogue Scale Pain Score (time frame: 1 month, 3 months, and 6 months post-treatment). The study lists 2 primary outcomes in all. 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 18 Aug 2026.