Proximal Humeral FracturePhase 2NCT00863473
Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
A Phase 2 study testing Surgical treatment with LCP in people with Proximal Humeral Fracture and Osteosynthesis or Conservative Treatment, run by University Hospital, Aker at 1 site in Norway.
Trial summary
1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? 2. Do surgical treatment gain more QALY than conservative treatment after one year? Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Proximal Humeral Fracture, Osteosynthesis or Conservative Treatment
- What is being tested?
- Surgical treatment with LCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- May 2003to May 2010
- Phase
- Phase 2
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital
Who cannot join
- aged less than 60 year
- patients of non-Scandinavian ethnicity
- previous history of injury or illness of the injured or contralateral shoulder
- injury of other part of the humerus or the contralateral upper extremity,
- alcohol- or drug abuse
- dementia or neurological diseases
- severe cardiovascular disease that would contraindicate surgery
Trial locations and contacts
1 site in 1 country.
Norway1 site
Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital
Oslo, N-0514
About this study
Official title: Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
- Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
- Do surgical treatment gain more QALY than conservative treatment after one year?
- Being tested
- Surgical treatment with LCP
- Keywords
- Proximal Humerus Fracture in elderly
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment with LCPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Conservative /Physiotherapy | No intervention | Active training protocol with instructed physiotherapy and self excercises |
| Surgery with LCP T plate | Active comparator | Surgical treatment with interlocking plate Receives: Procedure: Surgical treatment with LCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
Measured: 12 and 24 months
Secondary outcomes (3)
QALY (HRQoL score according to Harri Sintonen 15D and Costs)
Measured: 12 and 24 months
ASES score (modified self assessment) C) Radiographic score
Measured: 12 and 24 months
Radiographic score
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMay 2003
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proximal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aker
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Tore Fjalestad, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863473
- Sponsor's protocol ID
- AkerU_s422
- Status last verified
- Apr 2015
- First submitted
- 16 Mar 2009
- Last updated
- 23 Apr 2015
- Results posted
- No
Publications
Fjalestad T, Hole MO, Hovden IA, Blucher J, Stromsoe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012 Feb;26(2):98-106. doi: 10.1097/BOT.0b013e31821c2e15.
PubMed 21804410Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010 Jun;41(6):599-605. doi: 10.1016/j.injury.2009.10.056. Epub 2009 Nov 27.
PubMed 19945102Fjalestad T, Hole MO. Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial. Eur J Orthop Surg Traumatol. 2014 Oct;24(7):1067-73. doi: 10.1007/s00590-013-1403-y. Epub 2014 Jan 11.
PubMed 24413845
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00863473
- Acronym / sponsor ID
- AkerU_s422
- Keywords
- Proximal Humerus Fracture in elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AkerUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- May 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Mar 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.
- Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
- Do surgical treatment gain more QALY than conservative treatment after one year?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative /Physiotherapy | No intervention | –Active training protocol with instructed physiotherapy and self excercises |
| Surgery with LCP T plate | Active comparator | Procedure: Surgical treatment with LCPSurgical treatment with interlocking plate |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital
Key exclusion criteria (7 listed)
- aged less than 60 year
- patients of non-Scandinavian ethnicity
- previous history of injury or illness of the injured or contralateral shoulder
- injury of other part of the humerus or the contralateral upper extremity,
- alcohol- or drug abuse
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 |
|---|---|---|
| Surgical treatment with LCP | Procedure or surgery | Surgery with LCP T plate |
Primary outcome
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
Time frame: 12 and 24 months
3 secondary outcomes
QALY (HRQoL score according to Harri Sintonen 15D and Costs)
Time frame: 12 and 24 months
ASES score (modified self assessment) C) Radiographic score
Time frame: 12 and 24 months
Radiographic score
Time frame: 12 and 24 months
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 23 Apr 2015.
- Background: PubMed 21804410Fjalestad T, Hole MO, Hovden IA, Blucher J, Stromsoe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012 Feb;26(2):98-106. doi: 10.1097/BOT.0b013e31821c2e15.
- Background: PubMed 19945102Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010 Jun;41(6):599-605. doi: 10.1016/j.injury.2009.10.056. Epub 2009 Nov 27.
- Background: PubMed 24413845Fjalestad T, Hole MO. Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial. Eur J Orthop Surg Traumatol. 2014 Oct;24(7):1067-73. doi: 10.1007/s00590-013-1403-y. Epub 2014 Jan 11.
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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 Phase 2 study testing Surgical treatment with LCP in people with Proximal Humeral Fracture and Osteosynthesis or Conservative Treatment, run by University Hospital, Aker at 1 site in Norway.
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 1 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 23 Apr 2015. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). (time frame: 12 and 24 months). 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 NCT00863473, which also lists 3 linked publications.
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 23 Apr 2015.