Proximal Humeral FractureNCT03243409
Perioperative Complications in Reversed Shoulder Arthroplasties
An observational study of Proximal Humeral Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Retrospective observational study of reversed shoulder arthroplasties by proximal humeral fracture. Analysis of preoperative risk factors as well as minor and major complications at the first week, 90 days and 1 year. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jul 2017to 31 Aug 2017
- Phase
- Observational
- 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
- Older adult
Study population: Patients undergoing reversed shoulder arthroplasties owing to three or four parts fractures of the proximal humerus
Who may be able to join
- Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Laura Noguera, MD, lnoguera@santpau.cat
About this study
Official title: Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties
Retrospective observational study of reversed shoulder arthroplasties by proximal humeral fracture. Analysis of preoperative risk factors as well as minor and major complications at the first week, 90 days and 1 year.
Read the detailed description
The study is a multicenter retrospective observational study (3 centers). Data are collected from 105 patients over 65 years-old undergoing reversed shoulder arthroplasties by proximal humerus fractures, in 3 or 4 parts.
Patient information is obtained from the clinical records in their usual preoperative assessment, and follow-up on the usual routine checks, at the first week, 90 days and 1 year.
Minor and major complications rates are evaluated according to preoperative risk (ASA), underlying diseases and according to anticoagulant / antiaggregant treatments.
Likewise, transfusion rates related to ASA, as well as length of hospital stay related to it.
- Conditions
- Proximal Humeral Fracture
- Keywords
- reversed shoulder arthroplasties, clinical complications, complex proximal humeral fractures
- Medical subject headings
- Shoulder Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Measured: First week after surgery
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Measured: 90 days after surgery
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Measured: 1 year after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
Measured: First week after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
Measured: 90 days after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
Measured: 1 year after surgery
Secondary outcomes (16)
Number of patients affected by minor complications after surgery, according to underlying disease
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: First week after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: 90 days after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: 1 year after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: First week after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: 90 days after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Measured: 1 year after surgery
Number of patients undergoing anticoagulant treatment with minor complications
Previous acenocoumarol treatment
Measured: First week after surgery
Number of patients undergoing anticoagulant treatment with major complications
Previous acenocoumarol treatment
Measured: First week after surgery
Number of patients undergoing anticoagulant treatment with minor complications
Previous acenocoumarol treatment
Measured: 90 days after surgery
Number of patients undergoing anticoagulant treatment with major complications
Previous acenocoumarol treatment
Measured: 90 days after surgery
Number of patients undergoing antiplatelet treatment with minor complications
Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Measured: First week after surgery
Number of patients undergoing antiplatelet treatment with major complications
Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Measured: First week after surgery
Number of patients undergoing antiplatelet treatment with minor complications
Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Measured: 90 days after surgery
Number of patients undergoing antiplatelet treatment with major complications
Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Measured: 90 days after surgery
Transfusion rates according to the preoperative ASA group
Number of transfusion requirement.
Measured: 1 week after surgery
Length of hospital stay according to the preoperative ASA group
Length from the surgical intervention according to ASA risk
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start25 Jul 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carles Torrens Canovas, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243409
- Sponsor's protocol ID
- IIBSP-HUM-2017-51
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrel JR, Trinh TQ, Fischer RA. Reverse total shoulder arthroplasty versus hemiarthroplasty for proximal humeral fractures: a systematic review. J Orthop Trauma. 2015 Jan;29(1):60-8. doi: 10.1097/BOT.0000000000000224.
PubMed 25186842Boileau P, Winter M, Cikes A, Han Y, Carles M, Walch G, Schwartz DG. Can surgeons predict what makes a good hemiarthroplasty for fracture? J Shoulder Elbow Surg. 2013 Nov;22(11):1495-506. doi: 10.1016/j.jse.2013.04.018. Epub 2013 Jul 5.
PubMed 23834993Bufquin T, Hersan A, Hubert L, Massin P. Reverse shoulder arthroplasty for the treatment of three- and four-part fractures of the proximal humerus in the elderly: a prospective review of 43 cases with a short-term follow-up. J Bone Joint Surg Br. 2007 Apr;89(4):516-20. doi: 10.1302/0301-620X.89B4.18435.
PubMed 17463122Stanbury SJ, Voloshin I. Reverse shoulder arthroplasty for acute proximal humeral fractures in the geriatric patient: a review of the literature. Geriatr Orthop Surg Rehabil. 2011 Sep;2(5-6):181-6. doi: 10.1177/2151458511420140.
PubMed 23569688Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013 Nov 20;95(22):2050-5. doi: 10.2106/JBJS.L.01637.
PubMed 24257664Boyle MJ, Youn SM, Frampton CM, Ball CM. Functional outcomes of reverse shoulder arthroplasty compared with hemiarthroplasty for acute proximal humeral fractures. J Shoulder Elbow Surg. 2013 Jan;22(1):32-7. doi: 10.1016/j.jse.2012.03.006. Epub 2012 May 29.
PubMed 22652065Jones KJ, Dines DM, Gulotta L, Dines JS. Management of proximal humerus fractures utilizing reverse total shoulder arthroplasty. Curr Rev Musculoskelet Med. 2013 Mar;6(1):63-70. doi: 10.1007/s12178-013-9155-1.
PubMed 23334846Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011 Dec;469(12):3324-31. doi: 10.1007/s11999-011-2055-z.
PubMed 21879403Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Author reply: reverse total shoulder for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Sep;23(9):e222. doi: 10.1016/j.jse.2014.05.014. Epub 2014 Jul 24. No abstract available.
PubMed 25066822Acevedo DC, Vanbeek C, Lazarus MD, Williams GR, Abboud JA. Reverse shoulder arthroplasty for proximal humeral fractures: update on indications, technique, and results. J Shoulder Elbow Surg. 2014 Feb;23(2):279-89. doi: 10.1016/j.jse.2013.10.003.
PubMed 24418780Mata-Fink A, Meinke M, Jones C, Kim B, Bell JE. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. J Shoulder Elbow Surg. 2013 Dec;22(12):1737-48. doi: 10.1016/j.jse.2013.08.021.
PubMed 24246529Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014 Oct;23(10):1419-26. doi: 10.1016/j.jse.2014.06.035. Epub 2014 Jul 30.
PubMed 25086490Wall B, Walch G. Reverse shoulder arthroplasty for the treatment of proximal humeral fractures. Hand Clin. 2007 Nov;23(4):425-30, v-vi. doi: 10.1016/j.hcl.2007.08.002.
PubMed 18054669
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties
- ClinicalTrials.gov ID
- NCT03243409
- Acronym / sponsor ID
- IIBSP-HUM-2017-51
- Conditions
- Proximal Humeral Fracture
- Keywords
- reversed shoulder arthroplasties, clinical complications, complex proximal humeral fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 9 Aug 2017 (actual)
- 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.
Retrospective observational study of reversed shoulder arthroplasties by proximal humeral fracture. Analysis of preoperative risk factors as well as minor and major complications at the first week, 90 days and 1 year.
Detailed description
The study is a multicenter retrospective observational study (3 centers). Data are collected from 105 patients over 65 years-old undergoing reversed shoulder arthroplasties by proximal humerus fractures, in 3 or 4 parts.
Patient information is obtained from the clinical records in their usual preoperative assessment, and follow-up on the usual routine checks, at the first week, 90 days and 1 year.
Minor and major complications rates are evaluated according to preoperative risk (ASA), underlying diseases and according to anticoagulant / antiaggregant treatments.
Likewise, transfusion rates related to ASA, as well as length of hospital stay related to it.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients undergoing reversed shoulder arthroplasties owing to three or four parts fractures of the proximal humerus
Key inclusion criteria (1 listed)
- Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: First week after surgery
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: 90 days after surgery
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: 1 year after surgery
Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: First week after surgery
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: 90 days after surgery
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Time frame: 1 year after surgery
Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery
16 secondary outcomes
Number of patients affected by minor complications after surgery, according to underlying disease
Time frame: First week after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery
Time frame: 90 days after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery
Time frame: 1 year after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Time frame: First week after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Time frame: 90 days after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery
Time frame: 1 year after surgery
Number of patients undergoing anticoagulant treatment with minor complications
Time frame: First week after surgery
Number of patients undergoing anticoagulant treatment with major complications
Time frame: First week after surgery
Number of patients undergoing anticoagulant treatment with minor complications
Time frame: 90 days after surgery
Number of patients undergoing anticoagulant treatment with major complications
Time frame: 90 days after surgery
Number of patients undergoing antiplatelet treatment with minor complications
Time frame: First week after surgery
Number of patients undergoing antiplatelet treatment with major complications
Time frame: First week after surgery
Number of patients undergoing antiplatelet treatment with minor complications
Time frame: 90 days after surgery
Number of patients undergoing antiplatelet treatment with major complications
Time frame: 90 days after surgery
Transfusion rates according to the preoperative ASA group
Time frame: 1 week after surgery
Length of hospital stay according to the preoperative ASA group
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Background: PubMed 25186842Ferrel JR, Trinh TQ, Fischer RA. Reverse total shoulder arthroplasty versus hemiarthroplasty for proximal humeral fractures: a systematic review. J Orthop Trauma. 2015 Jan;29(1):60-8. doi: 10.1097/BOT.0000000000000224.
- Background: PubMed 23834993Boileau P, Winter M, Cikes A, Han Y, Carles M, Walch G, Schwartz DG. Can surgeons predict what makes a good hemiarthroplasty for fracture? J Shoulder Elbow Surg. 2013 Nov;22(11):1495-506. doi: 10.1016/j.jse.2013.04.018. Epub 2013 Jul 5.
- Background: PubMed 17463122Bufquin T, Hersan A, Hubert L, Massin P. Reverse shoulder arthroplasty for the treatment of three- and four-part fractures of the proximal humerus in the elderly: a prospective review of 43 cases with a short-term follow-up. J Bone Joint Surg Br. 2007 Apr;89(4):516-20. doi: 10.1302/0301-620X.89B4.18435.
- Background: PubMed 23569688Stanbury SJ, Voloshin I. Reverse shoulder arthroplasty for acute proximal humeral fractures in the geriatric patient: a review of the literature. Geriatr Orthop Surg Rehabil. 2011 Sep;2(5-6):181-6. doi: 10.1177/2151458511420140.
- Background: PubMed 24257664Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013 Nov 20;95(22):2050-5. doi: 10.2106/JBJS.L.01637.
- Background: PubMed 22652065Boyle MJ, Youn SM, Frampton CM, Ball CM. Functional outcomes of reverse shoulder arthroplasty compared with hemiarthroplasty for acute proximal humeral fractures. J Shoulder Elbow Surg. 2013 Jan;22(1):32-7. doi: 10.1016/j.jse.2012.03.006. Epub 2012 May 29.
- Background: PubMed 23334846Jones KJ, Dines DM, Gulotta L, Dines JS. Management of proximal humerus fractures utilizing reverse total shoulder arthroplasty. Curr Rev Musculoskelet Med. 2013 Mar;6(1):63-70. doi: 10.1007/s12178-013-9155-1.
- Background: PubMed 21879403Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011 Dec;469(12):3324-31. doi: 10.1007/s11999-011-2055-z.
- Background: PubMed 25066822Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Author reply: reverse total shoulder for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Sep;23(9):e222. doi: 10.1016/j.jse.2014.05.014. Epub 2014 Jul 24. No abstract available.
- Background: PubMed 24418780Acevedo DC, Vanbeek C, Lazarus MD, Williams GR, Abboud JA. Reverse shoulder arthroplasty for proximal humeral fractures: update on indications, technique, and results. J Shoulder Elbow Surg. 2014 Feb;23(2):279-89. doi: 10.1016/j.jse.2013.10.003.
- Background: PubMed 24246529Mata-Fink A, Meinke M, Jones C, Kim B, Bell JE. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. J Shoulder Elbow Surg. 2013 Dec;22(12):1737-48. doi: 10.1016/j.jse.2013.08.021.
- Background: PubMed 25086490Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014 Oct;23(10):1419-26. doi: 10.1016/j.jse.2014.06.035. Epub 2014 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Proximal Humeral Fracture
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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.
Carles Torrens Canovas study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Noguera Alonso (+34660708399, lnoguera@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures. (time frame: First week after surgery). The study lists 6 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 NCT03243409, which also lists 13 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 9 Aug 2017.