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

Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

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.

Study Overview

• Status: Withdrawn
• Conditions: Cuff Rotator Syndrome
• Intervention / Treatment: Radiation: MRI assessment

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrico Guerra, MD; Phone Number: 0516366567; Email: roberta.licciardi@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS):	Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "	At least 12 months after cuff rotator lesion surgery
Simple Shoulder Test (SST)	SST test consists of 12 questions about physical functioning with dichotomous response options (yes or no). Scores range from 0 (worst) to 100 (best) and are reported as the percentage of items answered in the affirmative by the patient	At least at leat 12 months after cuff rotator lesion surgery
Short Form-12 (SF-12):	SF-12 serves as a generic indicator of quality of life and assesses the individual's subjective perception of health, understood as biopsychosocial well-being. Through 12 of the 36 questions of the original questionnaire, the SF-12 investigates 8 different aspects related to health status: physical activity, role limitations due to physical health, emotional state, physical pain, perception of general health status, vitality, social activities and mental health; the synthesis of the total scores allows to build two synthetic indices, a physical health index (PCS-12) and a mental health index (MCS-12). The lower the score of the two indices, indicatively below 20 points, the greater the level of disability.	At least 12 months after cuff rotator lesion surgery
Treatment opinion post- surgery	Patient satisfaction with their post-surgery recovery status will be assessed.	At least 12 months after cuff rotator lesion surgery
Magnetic Resonance Imaging	Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction.	At least 12 months after cuff rotator lesion surgery

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: prospective study; retrospective study; cuff rotator; long-term clinical evaluation; long-term radiological evaluation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CUFF70

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No