Cuff Rotator SyndromeNCT05082844
Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
A study testing MRI assessment in people with Cuff Rotator Syndrome, run by Istituto Ortopedico Rizzoli.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cuff Rotator Syndrome
- What is being tested?
- MRI assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 13 Jan 2023
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Cuff Rotator Syndrome
- Being tested
- MRI assessment
- Keywords
- cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI assessmentRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: MRI assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At least 12 months after cuff rotator lesion surgery
Secondary outcomes (5)
Visual Analog Scale (VAS):
Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "
Measured: 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
Measured: 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.
Measured: At least 12 months after cuff rotator lesion surgery
Treatment opinion post- surgery
Patient satisfaction with their post-surgery recovery status will be assessed.
Measured: At least 12 months after cuff rotator lesion surgery
Magnetic Resonance Imaging
Magnetic Resonace Imaging will be carried for evaluating a possible plica retraction.
Measured: At least 12 months after cuff rotator lesion surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Oct 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: Institutional research funds needed to perform imaging examinations under the study protocol have expired due to organizational issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cuff Rotator SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082844
- Sponsor's protocol ID
- CUFF70
- Status last verified
- Sep 2022
- First submitted
- 9 Aug 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30572822Hattrup 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.
PubMed 7600171Merolla 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.
PubMed 23738239Yamaguchi K. Mini-open rotator cuff repair: an updated perspective. Instr Course Lect. 2001;50:53-61.
PubMed 11372355Robinson 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.
PubMed 23365029Geary MB, Elfar JC. Rotator Cuff Tears in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):220-4. doi: 10.1177/2151458515583895.
PubMed 26328240Charousset 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.
PubMed 20206038Bhatia 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.
PubMed 25834140
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70
- ClinicalTrials.gov ID
- NCT05082844
- Acronym / sponsor ID
- CUFF70
- Conditions
- Cuff Rotator Syndrome
- Keywords
- cuff rotator, retrospective study, prospective study, long-term clinical evaluation, long-term radiological evaluation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional research funds needed to perform imaging examinations under the study protocol have expired due to organizational issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 19 Oct 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion | Experimental | Radiation: MRI assessmentEvaluation 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI assessmentEvaluation 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 | Evaluation of clinical and radiographic findings after surgical treatment for cuff rotator lesion |
Primary outcome
Constant score
Time frame: At least 12 months after cuff rotator lesion surgery
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
5 secondary outcomes
Visual Analog Scale (VAS):
Time frame: At least 12 months after cuff rotator lesion surgery
Simple Shoulder Test (SST)
Time frame: At least at leat 12 months after cuff rotator lesion surgery
Short Form-12 (SF-12):
Time frame: At least 12 months after cuff rotator lesion surgery
Treatment opinion post- surgery
Time frame: At least 12 months after cuff rotator lesion surgery
Magnetic Resonance Imaging
Time frame: At least 12 months after cuff rotator lesion surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 30572822Longo 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.
- Background: PubMed 7600171Hattrup 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.
- Background: PubMed 23738239Merolla 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.
- Background: PubMed 11372355Yamaguchi K. Mini-open rotator cuff repair: an updated perspective. Instr Course Lect. 2001;50:53-61.
- Background: PubMed 23365029Robinson 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.
- Background: PubMed 26328240Geary MB, Elfar JC. Rotator Cuff Tears in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):220-4. doi: 10.1177/2151458515583895.
- Background: PubMed 20206038Charousset 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.
- Background: PubMed 25834140Bhatia 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MRI assessment in people with Cuff Rotator Syndrome, run by Istituto Ortopedico Rizzoli.
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 3 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: withdrawn, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score (time frame: At least 12 months after cuff rotator lesion surgery). 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 NCT05082844, which also lists 8 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 11 May 2023.