Humeral FractureNCT00999193
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial
A study testing locking plate, ORIF, Hemiarthroplasty and Conservative treatment in people with Humeral Fracture, run by University of Helsinki at 1 site in Finland.
Trial summary
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Humeral Fracture
- What is being tested?
- locking plate, ORIF, Hemiarthroplasty and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2010to 22 Feb 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years and older
- Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
- 3- or 4-part fracture with >5mm dislocation of the anatomic neck.
- AO classification C1-2 for non-luxation fractures
- AO classification C3 for luxation fractures
Who cannot join
- Head Splitting fracture
- Open fracture
- Additional fractures in the shoulder region
- Other injuries requiring surgical treatment
- Clinically significant injury of the brachial plexus or vasculature
- Pathological fracture associated with cancer
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- 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 Trauma Center, Helsinki University Central Hospital,
Helsinki
About this study
Official title: Effectiveness and Cost-effectiveness of Conservative and Operative Treatment of Three- and Four-part Fractures of the Proximal Humerus. A Nested Randomised Controlled Trial and Cohort Study
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation.
The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.
- Conditions
- Humeral Fracture
- Being tested
- locking plate, ORIF, Hemiarthroplasty, Conservative treatment
- Keywords
- Shoulder, Fracture, Locking Plate, Hemiarthroplasty, Conservative, Comminuted Proximal Humerus Fracture
- Medical subject headings
- Humeral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locking plate, ORIFProcedure or surgery
Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
HemiarthroplastyProcedure or surgery
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
Conservative treatmentOther
Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment | Active comparator | Not described Receives: Other: Conservative treatment |
| ORIF w. locking plate, no luxation | Experimental | Not described Receives: Procedure: locking plate, ORIF |
| Hemiarthroplasty, no luxation | Experimental | Not described Receives: Procedure: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest Numeric Rating Scale 0-10 (NRS)
Measured: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS
Measured: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Constant Score
Measured: 3 mo, 6 mo, 1 year, 2 years
Secondary outcomes (5)
Simple Shoulder Test (SST)
Measured: 3 mo, 6 mo, 1 year, 2 years
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 3 mo, 6 mo, 1 year, 2 years
Quality of life assessed with 15D
Measured: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Subjective satisfaction
Measured: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Complications
Measured: 6 weeks, 3 mo, 6 mo, 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.
- First posted21 Oct 2009 (estimated)
- Study startNov 2010
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: Recruitment decline and research question getting outdated
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Tuomas Lahdeoja, University of Helsinki
- Investigators
- Tuomas Lähdeoja, MD, Principal investigator, University of HelsinkiMika Paavola, MD, PhD, Study director, University of HelsinkiJarkko Pajarinen, MD, PhD, Study director, University of HelsinkiSeppo Koskinen, MD, PhD, Study chair, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999193
- Sponsor's protocol ID
- HUS-428/13/03/02/08
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2009
- 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
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
- Effectiveness and Cost-effectiveness of Conservative and Operative Treatment of Three- and Four-part Fractures of the Proximal Humerus. A Nested Randomised Controlled Trial and Cohort Study
- ClinicalTrials.gov ID
- NCT00999193
- Acronym / sponsor ID
- HUS-428/13/03/02/08
- Conditions
- Humeral Fracture
- Keywords
- Shoulder, Fracture, Locking Plate, Hemiarthroplasty, Conservative, Comminuted Proximal Humerus Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment decline and research question getting outdated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Finnish Institute for Health and Welfare
- Study start
- Nov 2010
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 21 Oct 2009 (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.
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation.
The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment | Active comparator | Other: Conservative treatment |
| ORIF w. locking plate, no luxation | Experimental | Procedure: locking plate, ORIF |
| Hemiarthroplasty, no luxation | Experimental | Procedure: Hemiarthroplasty |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 years and older
- Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
- 3- or 4-part fracture with >5mm dislocation of the anatomic neck.
Key exclusion criteria (10 listed)
- Head Splitting fracture
- Open fracture
- Additional fractures in the shoulder region
- Other injuries requiring surgical treatment
- Clinically significant injury of the brachial plexus or vasculature
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 |
|---|---|---|
| locking plate, ORIFOpen reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture. | Procedure or surgery | ORIF w. locking plate, no luxation |
| HemiarthroplastyReplacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures. | Procedure or surgery | Hemiarthroplasty, no luxation |
| Conservative treatmentImmobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury. | Other | Conservative Treatment |
Primary outcome
Pain at rest Numeric Rating Scale 0-10 (NRS)
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Constant Score
Time frame: 3 mo, 6 mo, 1 year, 2 years
5 secondary outcomes
Simple Shoulder Test (SST)
Time frame: 3 mo, 6 mo, 1 year, 2 years
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 3 mo, 6 mo, 1 year, 2 years
Quality of life assessed with 15D
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Subjective satisfaction
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Complications
Time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Results and safety
The study was stopped early (reason given: Recruitment decline and research question getting outdated). 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.
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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.
Tuomas Lähdeoja, MD principal investigator
University of Helsinki
Mika Paavola, MD, PhD study director
University of Helsinki
Jarkko Pajarinen, MD, PhD study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing locking plate, ORIF, Hemiarthroplasty and Conservative treatment in people with Humeral Fracture, run by University of Helsinki at 1 site in Finland.
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 10 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 and research question getting outdated). 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?
Pain at rest Numeric Rating Scale 0-10 (NRS) (time frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years). The study lists 3 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 NCT00999193, 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.