Proximal Humerus FractureNCT02362100
Proximal Humerus Fractures Randomized Control Trial
A study testing Non operative and locking plate surgical fixation in people with Proximal Humerus Fracture, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Proximal Humerus Fracture
- What is being tested?
- Non operative and locking plate surgical fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Jan 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced 2- or 3-part proximal humerus fractures by the Neer classification.
- Displaced 4-part proximal humeral fractures by the Neer classification that are deemed amenable to surgical fixation.
- > 60 years of age
- Low energy mechanism of injury
- Acute fracture (<3 weeks)
Who cannot join
- 4-part proximal humerus fractures that are not deemed amenable to surgical fixation (eg. due to osteopenic bone, thin head or tuberosity fragments); fractures that are better suited to treatment with arthroplasty
- Isolated greater tuberosity fractures
- Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
- Open fracture
- Previous ipsilateral shoulder surgery
- Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
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- Active joint or systemic infection
- Patients with convulsive disorders, collagen diseases, and any other conditions that might affect the mobility of the shoulder joint
- Major medical illness (life expectancy less than 2 years, unacceptably high operative risk, or not medically cleared by preoperative anesthesia consult)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Secondary outcomes will include an assessment of the ASES score, the SF-36 quality of life score, complication rates, re-operation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or posttraumatic osteoarthritis .
Read the detailed description
The design of this study is two-fold. The main study will be a prospective, single blind, randomized controlled trial (RCT). Patients will be randomized to either (1) non-operative treatment or (2) locking plate open reduction and internal fixation (ORIF).
The second component of this study will be a prospective, cohort study. This option will be presented to patients who do not want to enroll in the RCT because they prefer one treatment option over the other, and do not wish to be randomized to a treatment. Patients who choose either non-operative treatment or ORIF for their proximal humerus fracture will be followed for 2 years post injury.
Study Objectives:
Objective 1: Does a difference exist in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score over a 2-year follow-up period? Objective 2: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score, the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score, the International Physical Activity Questionnaire (IPAQ) for the elderly, and the EuroQol EQ-5D-5L Health Questionnaire Quality of Life (QoL) functional outcome score over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding (hematoma), reoperation rate, or hospital readmission over a 2-year follow-up period? Objective 3: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on radiographic outcomes including non-union, malunion, and joint arthrosis? Objective 4: Does the degree of initial displacement or angulation of the fracture fragments correlate with final functional outcome measures? Objective 5: Does the quality of the surgical reduction correlate with final functional outcome measures?
- Conditions
- Proximal Humerus Fracture
- Being tested
- Non operative, locking plate surgical fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non operativeOther
non operative treatment
locking plate surgical fixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| nonoperative management | Placebo comparator | Treatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows:
* 0 - 3 weeks: immobilization with a shoulder sling, range of motion of elbow, hand and wrist
* 3 - 6 weeks: same as 0-3 weeks, with addition of pendulum exercises every two hours
* After 6 weeks: Active mobilization and removal of sling. Light activity permitted and physiotherapy for range of motion permitted as tolerated.
* After 6 months: no further restriction will be placed. Full home and work activity permitted. Receives: Other: Non operative |
| locking plate surgical fixation | Active comparator | Standardized operative management protocol as follows:
* Pre-operative medical clearance established via anesthesia consults if required for medically complex patients.
* Provision of pre-operative intravenous (IV) antibiotic prophylaxis:
* Administration of general anesthetic.
* Patient positioning and preparation:
* Patient is carefully placed in the beach-chair position,
* Deltopectoral approach Fracture reduction and fixation with confirmation with intraoperative fluoroscopy images. Receives: Procedure: locking plate surgical fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant Score
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
Measured: From baseline to up until 24-Months Post-Operative
Secondary outcomes (2)
Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Measured: From baseline to up until 24-Months Post-Operative
Change in Short Form-36
The Short Form 36 (SF-36) is an outcome measure used to determine quality of life. This measure has 8 scaled scores, each question has equal weight and is then translated onto a scale graded from 0-100. A higher number indicates a better outcome.
Measured: From baseline to up until 24-Months Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: Due to low recruitment, lack of funding, and challenges maintaining follow-up in this patient population, a decision was made to terminate this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362100
- Sponsor's protocol ID
- 20150458-01H
- Status last verified
- May 2021
- First submitted
- 8 Feb 2015
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 35727196Howard L, Berdusco R, Momoli F, Pollock J, Liew A, Papp S, Lalonde KA, Gofton W, Ruggiero S, Lapner P. Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol. BMC Musculoskelet Disord. 2018 Aug 18;19(1):299. doi: 10.1186/s12891-018-2223-3.
PubMed 30121091
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Humerus Fractures Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02362100
- Acronym / sponsor ID
- 20150458-01H
- Conditions
- Proximal Humerus Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment, lack of funding, and challenges maintaining follow-up in this patient population, a decision was made to terminate this study.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 12 Feb 2015 (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.
The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Secondary outcomes will include an assessment of the ASES score, the SF-36 quality of life score, complication rates, re-operation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or posttraumatic osteoarthritis .
Detailed description
The design of this study is two-fold. The main study will be a prospective, single blind, randomized controlled trial (RCT). Patients will be randomized to either (1) non-operative treatment or (2) locking plate open reduction and internal fixation (ORIF).
The second component of this study will be a prospective, cohort study. This option will be presented to patients who do not want to enroll in the RCT because they prefer one treatment option over the other, and do not wish to be randomized to a treatment. Patients who choose either non-operative treatment or ORIF for their proximal humerus fracture will be followed for 2 years post injury.
Study Objectives:
Objective 1: Does a difference exist in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score over a 2-year follow-up period? Objective 2: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score, the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score, the International Physical Activity Questionnaire (IPAQ) for the elderly, and the EuroQol EQ-5D-5L Health Questionnaire Quality of Life (QoL) functional outcome score over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding (hematoma), reoperation rate, or hospital readmission over a 2-year follow-up period? Objective 3: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on radiographic outcomes including non-union, malunion, and joint arthrosis? Objective 4: Does the degree of initial displacement or angulation of the fracture fragments correlate with final functional outcome measures? Objective 5: Does the quality of the surgical reduction correlate with final functional outcome measures?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonoperative management | Placebo comparator | Other: Non operativeTreatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows: * 0 - 3 weeks: immobilization with a shoulder sling, range of motion of elbow, hand and wrist * 3 - 6 weeks: same as 0-3 weeks, with addition of pendulum exercises every two hours * After 6 weeks: Active mobilization and removal of sling. Light activity permitted and physiotherapy for range of motion permitted as tolerated. * After 6 months: no further restriction will be placed. Full home and work activity permitted. |
| locking plate surgical fixation | Active comparator | Procedure: locking plate surgical fixationStandardized operative management protocol as follows: * Pre-operative medical clearance established via anesthesia consults if required for medically complex patients. * Provision of pre-operative intravenous (IV) antibiotic prophylaxis: * Administration of general anesthetic. * Patient positioning and preparation: * Patient is carefully placed in the beach-chair position, * Deltopectoral approach Fracture reduction and fixation with confirmation with intraoperative fluoroscopy images. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Displaced 2- or 3-part proximal humerus fractures by the Neer classification.
- Displaced 4-part proximal humeral fractures by the Neer classification that are deemed amenable to surgical fixation.
- > 60 years of age
- Low energy mechanism of injury
- Acute fracture (<3 weeks)
Key exclusion criteria (12 listed)
- 4-part proximal humerus fractures that are not deemed amenable to surgical fixation (eg. due to osteopenic bone, thin head or tuberosity fragments); fractures that are better suited to treatment with arthroplasty
- Isolated greater tuberosity fractures
- Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
- Open fracture
- Previous ipsilateral shoulder 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 |
|---|---|---|
| Non operativenon operative treatment | Other | nonoperative management |
| locking plate surgical fixation | Procedure or surgery | locking plate surgical fixation |
Primary outcome
Change in Constant Score
Time frame: From baseline to up until 24-Months Post-Operative
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
2 secondary outcomes
Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
Time frame: From baseline to up until 24-Months Post-Operative
Change in Short Form-36
Time frame: From baseline to up until 24-Months Post-Operative
Results and safety
The study was stopped early (reason given: Due to low recruitment, lack of funding, and challenges maintaining follow-up in this patient population, a decision was made to terminate this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- 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.
- Derived from this study: PubMed 30121091Howard L, Berdusco R, Momoli F, Pollock J, Liew A, Papp S, Lalonde KA, Gofton W, Ruggiero S, Lapner P. Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol. BMC Musculoskelet Disord. 2018 Aug 18;19(1):299. doi: 10.1186/s12891-018-2223-3.
- Individual participant dataSharing planned: No
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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.
Peter Lapner, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non operative and locking plate surgical fixation in people with Proximal Humerus Fracture, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 12 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 17 May 2021. 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 Canada. 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. Some participants in this study may receive a placebo. 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: Due to low recruitment, lack of funding, and challenges maintaining follow-up in this patient population, a decision was made to terminate this study.). 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?
Change in Constant Score (time frame: From baseline to up until 24-Months Post-Operative). 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 NCT02362100, which also lists 2 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 17 May 2021.