Humeral FractureNCT01524965

The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

A study testing Immediate mobilisation after locking-plate osteosynthesis, Standard mobilisation after locking plate osteosynthesis and Osteosynthesis with a locking plate (Philos) in people with Humeral Fracture, run by University of Helsinki at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Humeral Fracture
What is being tested?: Immediate mobilisation after locking-plate osteosynthesis, Standard mobilisation after locking plate osteosynthesis and Osteosynthesis with a locking plate (Philos)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteFinland
Study dates: May 2011to 21 Oct 2023
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
Surgery can be performed within 10 days of injury
A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus

Who cannot join

Glenohumeral dislocation
Fracture of the Tuberculum Minus
Open fracture
Additional fractures in the shoulder region
Other injuries requiring surgical treatment
Clinically significant injury of the brachial plexus or vasculature

Show all 11Show fewer

Pathological fracture associated with cancer
History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
Rheumatoid Arthritis in the shoulder requiring active treatment
Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
Unwillingness to accept some of the treatment options.

Trial locations and contacts

1 site in 1 country.

Finland1 site

Töölö Hospital, Helsinki University Central Hospital
Helsinki, 00029

Other trials in Finland

About this study

Official title: The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.

Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.

Conditions: Humeral Fracture
Being tested: Immediate mobilisation after locking-plate osteosynthesis, Standard mobilisation after locking plate osteosynthesis, Osteosynthesis with a locking plate (Philos)
Keywords: Locking Plate, Physiotherapy
Medical subject headings: Humeral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate mobilisation after locking-plate osteosynthesisProcedure or surgery
Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively.
Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
Standard mobilisation after locking plate osteosynthesisProcedure or surgery
Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks.
Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
Osteosynthesis with a locking plate (Philos)Device
Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.

Study groups in NCT01524965
Study group	Role	What they receive
Immediate mobilisation	Experimental	Not described Receives: Procedure: Immediate mobilisation after locking-plate osteosynthesis; Device: Osteosynthesis with a locking plate (Philos)
Standard mobilisation	Active comparator	Not described Receives: Procedure: Standard mobilisation after locking plate osteosynthesis; Device: Osteosynthesis with a locking plate (Philos)

What is being measured

The primary outcome is the main question the study is designed to answer.

Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 3 weeks
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 6 weeks
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 3 months
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 6 months
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 1 year
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Measured: 2 years

Secondary outcomes (6)

Constant Score
subjective and objective shoulder score
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Simple Shoulder Test (SST)
another shoulder score
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pain in rest and motion (2 different values)
Numeric rating scale 0-10
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Subjective satisfaction
Patient reported, Numeric Rating Scale 0-10
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Quality of Life
Using the 15D instrument
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Complications
Complications of surgery and postoperative phase
Measured: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201121 Oct 2023

First posted2 Feb 2012 (estimated)
Study startMay 2011
Primary completion11 Oct 2023
Study completion21 Oct 2023

Why it stopped: Recruitment decline due to change in clinical practice to less surgery for the fractures of interest

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Humeral 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01524965
Sponsor's protocol ID: HUS-272/13/03/02/2010
Status last verified: Jan 2025
First submitted: 22 Jan 2012
Last updated: 7 Jan 2025
Results posted: No
Data monitoring committee: No

Publications

Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingObservational study
Tornier Perform™ Reversed Monopost Study
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture

All Humeral Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.
ClinicalTrials.gov ID: NCT01524965
Acronym / sponsor ID: HUS-272/13/03/02/2010
Conditions: Humeral Fracture
Keywords: Locking Plate, Physiotherapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment decline due to change in clinical practice to less surgery for the fractures of interest
Enrolment: 94 participants (actual)
Lead sponsor: University of HelsinkiUniversity, hospital or other
Collaborators: Finnish Institute for Health and Welfare
Study start: May 2011
Primary completion: 11 Oct 2023 (actual)
Study completion: 21 Oct 2023 (actual)
First posted: 2 Feb 2012 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Immediate mobilisation	Experimental	Procedure: Immediate mobilisation after locking-plate osteosynthesis, Device: Osteosynthesis with a locking plate (Philos)
Standard mobilisation	Active comparator	Procedure: Standard mobilisation after locking plate osteosynthesis, Device: Osteosynthesis with a locking plate (Philos)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18 years or older
Surgery can be performed within 10 days of injury
A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus

Key exclusion criteria (11 listed)

Glenohumeral dislocation
Fracture of the Tuberculum Minus
Open fracture
Additional fractures in the shoulder region
Other injuries requiring surgical treatment

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
Immediate mobilisation after locking-plate osteosynthesisImmediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.	Procedure or surgery	Immediate mobilisation
Standard mobilisation after locking plate osteosynthesisImmediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.	Procedure or surgery	Standard mobilisation
Osteosynthesis with a locking plate (Philos)Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.	Device	Immediate mobilisation, Standard mobilisation

Primary outcome

Disablities of Arm, Hand and Shoulder
Time frame: 3 weeks
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Time frame: 6 weeks
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Time frame: 3 months
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Time frame: 6 months
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Time frame: 1 year
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Time frame: 2 years
Validated patient-reported upper extremity function scale

6 secondary outcomes

Constant Score
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Simple Shoulder Test (SST)
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pain in rest and motion (2 different values)
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Subjective satisfaction
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Quality of Life
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Complications
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Results and safety

The study was stopped early (reason given: Recruitment decline due to change in clinical practice to less surgery for the fractures of interest). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Related trials for Humeral Fracture

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingObservational study
Tornier Perform™ Reversed Monopost Study
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture

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.

Tuomas Lähdeoja, MD principal investigator

Helsinki University Central Hospital

Mika Paavola, MD, PhD study director

Helsinki University Central Hospital

Jarkko Pajarinen, MD, PhD study director

Helsinki University Central Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 Jan 2025. 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 Finland. 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 was stopped early (reason given: Recruitment decline due to change in clinical practice to less surgery for the fractures of interest). Results are not available in the source record.

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?

Disablities of Arm, Hand and Shoulder (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01524965, which also lists 1 linked publication.

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 7 Jan 2025.