Clinical trial NCT05082844: Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
Official title: Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cuff Rotator Syndrome
Keywords: cuff rotator
retrospective study
prospective study
long-term clinical evaluation
long-term radiological evaluation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to document the clinical-radiological results from the case series of patients surgically treated for rotator cuff lesions from 2009 to 2020 at the Rizzoli Orthopaedic Institute Shoulder-Elbow Department.

Detailed description: 110 patients surgically treated for rotator cuff lesions from 2009 to 2020 will be included in a retrospective-prospective and interventional study with clinical and radiological evaluation at follow-up of at least 12 months.

Eligibility criteria: Inclusion Criteria:

1. ≥70 years of age at the time of rotator cuff repair surgery
2. Males and Females
3. Patients surgically treated for rotator cuff injury between 2009 and 2020 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute

Exclusion Criteria:

* All available patients will be invited to undergo clinical examination and radiological examination. In case some patients cannot undergo MRI due to possible contraindications, they will still be seen to collect the primary clinical outcome

Primary outcomes:
measure: Constant score
timeFrame: At least 12 months after cuff rotator lesion surgery
Secondary outcomes:
measure: Visual Analog Scale (VAS):
timeFrame: At least 12 months after cuff rotator lesion surgery
measure: Simple Shoulder Test (SST)
timeFrame: At least at leat 12 months after cuff rotator lesion surgery
measure: Short Form-12 (SF-12):
timeFrame: At least 12 months after cuff rotator lesion surgery
measure: Treatment opinion post- surgery
timeFrame: At least 12 months after cuff rotator lesion surgery
measure: Magnetic Resonance Imaging
timeFrame: At least 12 months after cuff rotator lesion surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Longo UG, Margiotti K, Petrillo S, Rizzello G, Fusilli C, Maffulli N, De Luca A, Denaro V. Genetics of rotator cuff tears: no association of col5a1 gene in a case-control study. BMC Med Genet. 2018 Dec 20;19(1):217. doi: 10.1186/s12881-018-0727-1.
citation: Hattrup SJ. Rotator cuff repair: relevance of patient age. J Shoulder Elbow Surg. 1995 Mar-Apr;4(2):95-100. doi: 10.1016/s1058-2746(05)80061-8.
citation: Merolla G, Paladini P, Saporito M, Porcellini G. Conservative management of rotator cuff tears: literature review and proposal for a prognostic. Prediction Score. Muscles Ligaments Tendons J. 2011 Oct 30;1(1):12-9. Print 2011 Jan.
citation: Yamaguchi K. Mini-open rotator cuff repair: an updated perspective. Instr Course Lect. 2001;50:53-61.
citation: Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302/0301-620X.95B2.30246.
citation: Geary MB, Elfar JC. Rotator Cuff Tears in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):220-4. doi: 10.1177/2151458515583895.
citation: Charousset C, Bellaiche L, Kalra K, Petrover D. Arthroscopic repair of full-thickness rotator cuff tears: is there tendon healing in patients aged 65 years or older? Arthroscopy. 2010 Mar;26(3):302-9. doi: 10.1016/j.arthro.2009.08.027.
citation: Bhatia S, Greenspoon JA, Horan MP, Warth RJ, Millett PJ. Two-Year Outcomes After Arthroscopic Rotator Cuff Repair in Recreational Athletes Older Than 70 Years. Am J Sports Med. 2015 Jul;43(7):1737-42. doi: 10.1177/0363546515577623. Epub 2015 Apr 1.