Perioperative Complications in Reversed Shoulder Arthroplasties

Proximal Humeral Fracture Clinical Trial

Official title:

Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03243409
• Other study ID #: IIBSP-HUM-2017-51
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 3, 2017
• Start date: July 25, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Laura Noguera Alonso
• Phone: +34660708399
• Email: lnoguera[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Acevedo 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. Review. — View Citation

Boileau 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. — View Citation

Boyle 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. — View Citation

Bufquin 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. — View Citation

Chalmers 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. — View Citation

Cuff 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. — View Citation

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. Review. — View Citation

Jones 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. — View Citation

Lenarz 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. — View Citation

Mata-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. Review. — View Citation

Sebastiá-Forcada E, Cebrián-Gómez R, Lizaur-Utrilla A, Gil-Guillén 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. — View Citation

Stanbury 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. — View Citation

Wall B, Walch G. Reverse shoulder arthroplasty for the treatment of proximal humeral fractures. Hand Clin. 2007 Nov;23(4):425-30, v-vi. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First week after surgery
Primary	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	90 days after surgery
Primary	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	1 year after surgery
Primary	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	First week after surgery
Primary	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	90 days after surgery
Primary	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	1 year after surgery
Secondary	Number of patients affected by minor complications after surgery, according to underlying disease	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	First week after surgery
Secondary	Number of patients with cardiovascular diseases affected by minor complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	90 days after surgery
Secondary	Number of patients with cardiovascular diseases affected by minor complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	1 year after surgery
Secondary	Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	First week after surgery
Secondary	Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	90 days after surgery
Secondary	Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	1 year after surgery
Secondary	Number of patients undergoing anticoagulant treatment with minor complications	Previous acenocoumarol treatment	First week after surgery
Secondary	Number of patients undergoing anticoagulant treatment with major complications	Previous acenocoumarol treatment	First week after surgery
Secondary	Number of patients undergoing anticoagulant treatment with minor complications	Previous acenocoumarol treatment	90 days after surgery
Secondary	Number of patients undergoing anticoagulant treatment with major complications	Previous acenocoumarol treatment	90 days after surgery
Secondary	Number of patients undergoing antiplatelet treatment with minor complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	First week after surgery
Secondary	Number of patients undergoing antiplatelet treatment with major complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	First week after surgery
Secondary	Number of patients undergoing antiplatelet treatment with minor complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	90 days after surgery
Secondary	Number of patients undergoing antiplatelet treatment with major complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	90 days after surgery
Secondary	Transfusion rates according to the preoperative ASA group	Number of transfusion requirement.	1 week after surgery
Secondary	Length of hospital stay according to the preoperative ASA group	Length from the surgical intervention according to ASA risk	1 week after surgery