Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

NCT05082844 | Withdrawn

• 1 other identifier: CUFF70
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cuff Rotator Syndrome

Keywords

cuff rotator; retrospective study; prospective study; long-term clinical evaluation; long-term radiological evaluation

Outcome Measures

Primary Outcomes (1)

• Constant score

  The constant score is the most commonly used questionnaire for evaluating treatment outcomes of shoulder disorders. It's the scoring system recommended by the European Society of Shoulder and Elbow Surgery (SECEC / ESSE). It has the advantages of including pain score, functional assessment, range of motion, and strength measures. A high score corresponds to a great quality of function

  At least 12 months after cuff rotator lesion surgery

Secondary Outcomes (5)

• Visual Analog Scale (VAS):

  At least 12 months after cuff rotator lesion surgery

• Simple Shoulder Test (SST)

  At least at leat 12 months after cuff rotator lesion surgery

• Short Form-12 (SF-12):

  At least 12 months after cuff rotator lesion surgery

• Treatment opinion post- surgery

  At least 12 months after cuff rotator lesion surgery

• Magnetic Resonance Imaging

  At least 12 months after cuff rotator lesion surgery

Study Arms (1)

Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion

EXPERIMENTAL

Evaluation of the clinical-radiological results from the case series of patients surgically treated for cuff rotator lesions from 2009 to 2020 at the Shoulder-Elbow Department . At 12 months the result is considered stabilized, so we will proceed to collect all case histories that have passed this follow-up period.

Radiation: MRI assessment

Interventions

MRI assessment RADIATION

Evaluation of the clinical-radiological results from the case series of patients surgically treated for cuff rotator lesions from 2009 to 2020 at the Shoulder-Elbow Department . At 12 months the result is considered stabilized, so we will proceed to collect all case histories that have passed this follow-up period.

Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Related Publications (8)

• 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.

  PMID: 30572822 BACKGROUND

• 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.

  PMID: 7600171 BACKGROUND

• 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.

  PMID: 23738239 BACKGROUND

• Yamaguchi K. Mini-open rotator cuff repair: an updated perspective. Instr Course Lect. 2001;50:53-61.

  PMID: 11372355 BACKGROUND

• 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.

  PMID: 23365029 BACKGROUND

• 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.

  PMID: 26328240 BACKGROUND

• 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.

  PMID: 20206038 BACKGROUND

• 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.

  PMID: 25834140 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: October 19, 2021
• Study Start: October 1, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: May 11, 2023

Record last verified: 2022-09