A02.835.232.087.090.400.400NCT02075476
Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures
A study testing Hemiarthroplasty and reverse arthroplasty in people with A02.835.232.087.090.400.400, run by Carlos Alvarez at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- A02.835.232.087.090.400.400
- What is being tested?
- Hemiarthroplasty and reverse arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to 6 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
- Patient 70 years older
- Signed informed consent.
Who cannot join
- Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…)
- Glenohumeral osteoarthritis
- Inflammatory arthropathies
- Previous cuff arthropatyy
- High surgical or anesthesia risk
- Any disease or condition that the investigator finds decisive for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized and Double Blind Study of Parallels Groups for Evaluating the Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures in Three or Four Fragments
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
Read the detailed description
Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.
- Conditions
- A02.835.232.087.090.400.400
- Being tested
- Hemiarthroplasty, reverse arthroplasty
- Keywords
- Fracture-luxation, humeral proximal extremity, Hemiarthroplasty, reverse Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiarthroplastyProcedure or surgery
reverse arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty Global Fx(DePuy) | Active comparator | in this technique the prosthesis is implanted in similar approach to shoulder anatomy Receives: Procedure: Hemiarthroplasty |
| reverse arthroplasty Delta Xtent(DePuy) | Experimental | In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy Receives: Procedure: reverse arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured.
The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 36 months
Effectiveness Will be Measured for Constant Score
changes in Constant score will be measured.
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: 36 months
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured.
The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMay 2013
- Primary completion5 Aug 2015
- Study completion6 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for A02.835.232.087.090.400.400Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos Alvarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos Alvarez, Hospital General Universitario Gregorio Marañon
- Investigators
- Carlos Alvarez, MD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075476
- Sponsor's protocol ID
- FRALUX-34
- Status last verified
- Apr 2020
- First submitted
- 6 Feb 2014
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized and Double Blind Study of Parallels Groups for Evaluating the Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures in Three or Four Fragments
- ClinicalTrials.gov ID
- NCT02075476
- Acronym / sponsor ID
- FRALUX-34
- Conditions
- A02.835.232.087.090.400.400
- Keywords
- Fracture-luxation, humeral proximal extremity, Hemiarthroplasty, reverse Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Carlos AlvarezUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 5 Aug 2015 (actual)
- Study completion
- 6 Aug 2016 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
Detailed description
Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty Global Fx(DePuy) | Active comparator | Procedure: Hemiarthroplastyin this technique the prosthesis is implanted in similar approach to shoulder anatomy |
| reverse arthroplasty Delta Xtent(DePuy) | Experimental | Procedure: reverse arthroplastyIn this technique the prosthesis is implanted in the inverse mode of shoulder anatomy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
- Patient 70 years older
- Signed informed consent.
Key exclusion criteria (6 listed)
- Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…)
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 |
|---|---|---|
| Hemiarthroplasty | Procedure or surgery | Hemiarthroplasty Global Fx(DePuy) |
| reverse arthroplasty | Procedure or surgery | reverse arthroplasty Delta Xtent(DePuy) |
Primary outcome
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
Time frame: 36 months
changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Effectiveness Will be Measured for Constant Score
Time frame: 36 months
changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
Time frame: 36 months
changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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.
Carlos Alvarez, MD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiarthroplasty and reverse arthroplasty in people with A02.835.232.087.090.400.400, run by Carlos Alvarez at 1 site in Spain.
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 6 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 14 Apr 2020. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score (time frame: 36 months). 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 NCT02075476, 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 14 Apr 2020.