HumerusNCT01984112
Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts
A study testing Locked plate and Intramedullary locked nail in people with Humerus and Proximal Humeral Fracture, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Humerus, Proximal Humeral Fracture, Fractures, Bone
- What is being tested?
- Locked plate and Intramedullary locked nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Apr 2015
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fracture with less than 21 days;
- Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
- Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
- Closed fractures;
Who cannot join
- Characteristics of the fracture:
- fracture between the greater tubercle and the smaller, independent of the deviation;
- Isolated fracture of the greater or lesser tuberosity
- 4-part fractures of Neer;
- Fracture involving the articular surface of the humeral head;
- Fracture-dislocation of the proximal humerus
Show all 14Show fewer
- Other criteria:
- Neurological injuries in the affected limb;
- previous surgery on the affected shoulder;
- associated fractures in the affected limb;
- pathologic fractures;
- lesions of the rotator cuff tendons previously diagnosed;
- Psychiatric illnesses or inability to understand preoperative questionnaires;
- Active infection or previous infection on the shoulder;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, 05403-010
About this study
Official title: Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures
The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.
- Conditions
- Humerus, Proximal Humeral Fracture, Fractures, Bone, Humeral Fractures, Wounds and Injuries, Arm Injuries
- Being tested
- Locked plate, Intramedullary locked nail
- Keywords
- Humerus, fracture, nail, plate, tuberosity
- Medical subject headings
- Shoulder Fractures, Fractures, Bone, Humeral Fractures, Wounds and Injuries, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locked plateDevice
Also called Philos plaste, Synthes, Switzerland
Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture
Intramedullary locked nailDevice
Also called Centronail, Proximal Humeral Nail, Orthofix, Italy
Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary Locked Nail | Experimental | Not described Receives: Device: Intramedullary locked nail |
| Locked Plate | Active comparator | Not described Receives: Device: Locked plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
Absolute Constant-Murley Score, that measures:
Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome
Measured: 12 months
Secondary outcomes (4)
Superior limb function, measured by DASH score
Disability of Arm-Shoulder-Hand score
Measured: 12 months
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score.
0-35 points score
Measured: 12 months
Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score
Individual Relative Constant-Murley Score, compared to non-injured shoulder.
Fialka C, Oberleitner G, Stampfl P, Brannath W, Hexel M, Vécsei V. Modification of the Constant-Murley shoulder score-introduction of the individual relative Constant score Individual shoulder assessment. Injury. 2005 Oct;36(10):1159-65.
Measured: 12 months
Number of patients with complications
Overall complications and need for additional surgery, categorized as:
Not related to implant
Clinical
- Death in the intraoperative or postoperative period;
- Clinical complications related to surgery .
Orthopedic
- Infection
- Osteonecrosis ;
- Nonunion ;
- Stiffness
- Reflex sympathetic dystrophy ;
- Heterotopic ossification ;
- Refracture ;
- Neurological injury .
- Insufficient reduction;
- Loss of reduction of the humeral head;
- Loss of reduction of tubercule: deviation greater than 5 mm between the immediate postoperative radiographs and 12 months;
Related to the implant
- Primary articular protrusion of screws;
- Loosening of the implant ;
- Breaking of the implant ;
- Cutout: loss reduction head with proximal screw pullout ;
- secondary articular protrusion screws;
- Malunion
- Injury to the rotator cuff tendons is observed in postoperative ultrasonography;
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startMay 2011
- Primary completionMar 2015
- Study completionApr 2015
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 HumerusStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Gracitelli, University of Sao Paulo
- Investigators
- Mauro EC Gracitelli, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984112
- Sponsor's protocol ID
- 0232/11
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2013
- Last updated
- 5 Oct 2015
- 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 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures
- ClinicalTrials.gov ID
- NCT01984112
- Acronym / sponsor ID
- 0232/11
- Conditions
- Humerus, Proximal Humeral Fracture, Fractures, Bone, Humeral Fractures, Wounds and Injuries, Arm Injuries
- Keywords
- Humerus, fracture, nail, plate, tuberosity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Nov 2013 (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 hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary Locked Nail | Experimental | Device: Intramedullary locked nail |
| Locked Plate | Active comparator | Device: Locked plate |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fracture with less than 21 days;
- Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
- Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
- Closed fractures;
Key exclusion criteria (14 listed)
- Characteristics of the fracture:
- Other criteria:
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 |
|---|---|---|
| Locked plateAlso: Philos plaste, Synthes, SwitzerlandOsteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture | Device | Locked Plate |
| Intramedullary locked nailAlso: Centronail, Proximal Humeral Nail, Orthofix, ItalyIntramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture | Device | Intramedullary Locked Nail |
Primary outcome
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
Time frame: 12 months
Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome
4 secondary outcomes
Superior limb function, measured by DASH score
Time frame: 12 months
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score
Time frame: 12 months
Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score
Time frame: 12 months
Number of patients with complications
Time frame: 12 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 5 Oct 2015.
- 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.
Mauro EC Gracitelli, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locked plate and Intramedullary locked nail in people with Humerus and Proximal Humeral Fracture, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 14 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 5 Oct 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 Brazil. 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 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?
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score (time frame: 12 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 NCT01984112, 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 5 Oct 2015.