Rotator Cuff TearsNCT07001566
The Impact of Cervical Radiculopathy on Functionality in Patients Undergoing Rotator Cuff Repair
An observational study of Rotator Cuff Tears, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the impact of cervical radiculopathy on functional status and quality of life outcomes in patients who have undergone rotator cuff repair, comparing the group with a history of cervical radiculopathy to the group without cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 41 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 41 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted on 50 patients who underwent rotator cuff surgery between 2018 and 2023, with a mean age of 53.74 ± 6.58 years, 54% of whom were female
Who may be able to join
- Patients who have undergone rotator cuff repair
- Patients under the age of 65
Who cannot join
- Patients who have undergone shoulder surgery other than rotator cuff repair
- Patients with a history of cervical spine surgery
- Patients with any neurological disorders
- Patients with a history of pathological fractures
- Patients with oncological diseases
- Patients with a history of infection
- Patients who were deceased at the time of retrospective screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Lütfi Kırdar City Hospital
Istanbul, Istanbul, 34870
ömer hekim, 05547538348, omerfarukhekim@gmail.com
About this study
Official title: The Impact of Cervical Radiculopathy on Functionality and Quality of Life in Patients Undergoing Rotator Cuff Repair
The aim of the study is to evaluate the impact of cervical radiculopathy on functional status and quality of life outcomes in patients who have undergone rotator cuff repair, comparing the group with a history of cervical radiculopathy to the group without cervical radiculopathy.
Study topic: The participants of the study were selected from patients who underwent rotator cuff repair at the Orthopedics and Traumatology clinic of Kartal Dr. Lütfi Kırdar City Hospital between 2018 and 2023. The first group consisted of patients without cervical radiculopathy, while the second group included patients with a previously diagnosed cervical radiculopathy. The study will examine the effect of the presence of cervical radiculopathy on functional outcomes and quality of life in patients who underwent rotator cuff repair.
Read the detailed description
Shoulder surgery is an important part of modern orthopedic and traumatology practice. Open or closed (arthroscopic) instability and rotator cuff surgeries are the most frequently performed procedures in shoulder surgery.The relationship between cervical spine and rotator cuff pathology has been studied, and the existence of this relationship has been confirmed. Shoulder pain is often associated with rotator cuff tears. Shoulder pain can also result from an external cause, such as cervical radiculopathy. Such a pain source, in conjunction with a rotator cuff tear, can somewhat affect the treatment process of the cuff tear.
Cervical radiculopathy occurs when a nerve root in the spine is compressed or blocked, leading to pain that can radiate beyond the neck, to the arm, chest, shoulders, and upper back. Common symptoms of compression include muscle weakness and impaired deep tendon reflexes. These deficiencies can worsen over time, leading to a decline in quality of life and daily function. While most symptoms can be treated with supportive care, more severe functional loss may require rehabilitation or surgery. Any condition that causes compression or irritation of the spinal nerve root can lead to radicular symptoms. In younger patients, typically in their third and fourth decades, disc trauma and herniation are the most common causes of compression. As age increases, the cause tends to be degenerative. Disc degeneration is the most common cause in the fifth and sixth decades. In the seventh decade, it results from arthritic changes due to foraminal narrowing. Cervical radiculopathies are less frequently seen than lumbar radiculopathies, occurring in approximately 85 per 100,000 people. The C7 nerve root is most frequently affected, with more than half of all cases involving this level. About a quarter of cases involve the C6 nerve root. The C1 to C5 and C8 nerve roots are less affected. Risk factors for developing radicular disease include manual labor such as heavy lifting, driving, or operating vibrating equipment (Magnus, 2024).
Rotator cuff syndrome, also known as rotator cuff tear, is an injury that affects the shoulder, causing pain and inability to use the arm due to the tearing of the muscles and tendons in the rotator cuff. Rotator cuff syndrome can be partial or complete, and is typically caused by injury, trauma, or degeneration. Rotator cuff surgery is rapidly advancing, with most progress driven by improvements in arthroscopic techniques. Generally, functional outcomes are satisfactory. Tendon healing is associated with better results, especially with more strength. Therefore, the best candidates for surgery are those with lesions that have a high likelihood of recovery. Factors associated with recovery include being under 65 years old, having had a recent tear, no history of smoking, having an acromiohumeral distance greater than 6 mm, and a Goutallier fatty degeneration grade of less than 2 in the infraspinatus or subscapularis muscles.
A retrospective cohort study investigated the relationship between cervical spine and rotator cuff pathology and confirmed the existence of this relationship.
In a previous study, it was shown that patients with a history of cervical spine issues who underwent shoulder surgery had lower postoperative functional outcomes, lower satisfaction, and higher rates of postoperative complications requiring surgical revision, compared to patients without cervical spine issues. Another study, focusing on a cohort of patients who underwent shoulder surgery, showed that the short-term postoperative outcomes of patients with cervical spine pathology were significantly lower compared to the functional outcomes of patients without cervical spine pathology.
The sample size was calculated using the G*Power 3.1.9.7 program. The logistic regression test was used, with α error set at 0.20 and 80% power. The odds ratio value from Zhang et al.'s (2015) study, titled The Association Between Cervical Spine Pathology and Rotator Cuff Dysfunction, was used as a reference for patients diagnosed with cervical pathology who developed rotator cuff injury or underwent surgery within a five-year period. Based on this value, the required sample size to achieve 80% power was calculated to be 78 participants.
- Conditions
- Rotator Cuff Tears
- Being tested
- There was no intervention. Only assessment procedure will be performed.
- Keywords
- pain, functionality, quality of life
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There was no intervention. Only assessment procedure will be performed.Other
There was no intervention. Only assessment procedure will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patient's who has cervical radiculopathy | There will be only done assessment. Receives: Other: There was no intervention. Only assessment procedure will be performed. | |
| Patient's who has not cervical radiculopathy | There will be only done assessment. Receives: Other: There was no intervention. Only assessment procedure will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality and quality of life
Measured: Between the years 2018 and 2023
Secondary outcomes (1)
pain perception
Measured: Between the years 2018 and 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start20 Mar 2025
- Primary completion20 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guzin Kaya Aytutuldu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001566
- Sponsor's protocol ID
- Biruni University PTR
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cervical Radiculopathy on Functionality and Quality of Life in Patients Undergoing Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07001566
- Acronym / sponsor ID
- Biruni University PTR
- Conditions
- Rotator Cuff Tears
- Keywords
- pain, functionality, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Jun 2025 (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 evaluate the impact of cervical radiculopathy on functional status and quality of life outcomes in patients who have undergone rotator cuff repair, comparing the group with a history of cervical radiculopathy to the group without cervical radiculopathy.
Study topic: The participants of the study were selected from patients who underwent rotator cuff repair at the Orthopedics and Traumatology clinic of Kartal Dr. Lütfi Kırdar City Hospital between 2018 and 2023. The first group consisted of patients without cervical radiculopathy, while the second group included patients with a previously diagnosed cervical radiculopathy. The study will examine the effect of the presence of cervical radiculopathy on functional outcomes and quality of life in patients who underwent rotator cuff repair.
Detailed description
Shoulder surgery is an important part of modern orthopedic and traumatology practice. Open or closed (arthroscopic) instability and rotator cuff surgeries are the most frequently performed procedures in shoulder surgery.The relationship between cervical spine and rotator cuff pathology has been studied, and the existence of this relationship has been confirmed. Shoulder pain is often associated with rotator cuff tears. Shoulder pain can also result from an external cause, such as cervical radiculopathy. Such a pain source, in conjunction with a rotator cuff tear, can somewhat affect the treatment process of the cuff tear.
Cervical radiculopathy occurs when a nerve root in the spine is compressed or blocked, leading to pain that can radiate beyond the neck, to the arm, chest, shoulders, and upper back. Common symptoms of compression include muscle weakness and impaired deep tendon reflexes. These deficiencies can worsen over time, leading to a decline in quality of life and daily function. While most symptoms can be treated with supportive care, more severe functional loss may require rehabilitation or surgery. Any condition that causes compression or irritation of the spinal nerve root can lead to radicular symptoms. In younger patients, typically in their third and fourth decades, disc trauma and herniation are the most common causes of compression. As age increases, the cause tends to be degenerative. Disc degeneration is the most common cause in the fifth and sixth decades. In the seventh decade, it results from arthritic changes due to foraminal narrowing. Cervical radiculopathies are less frequently seen than lumbar radiculopathies, occurring in approximately 85 per 100,000 people. The C7 nerve root is most frequently affected, with more than half of all cases involving this level. About a quarter of cases involve the C6 nerve root. The C1 to C5 and C8 nerve roots are less affected. Risk factors for developing radicular disease include manual labor such as heavy lifting, driving, or operating vibrating equipment (Magnus, 2024).
Rotator cuff syndrome, also known as rotator cuff tear, is an injury that affects the shoulder, causing pain and inability to use the arm due to the tearing of the muscles and tendons in the rotator cuff. Rotator cuff syndrome can be partial or complete, and is typically caused by injury, trauma, or degeneration. Rotator cuff surgery is rapidly advancing, with most progress driven by improvements in arthroscopic techniques. Generally, functional outcomes are satisfactory. Tendon healing is associated with better results, especially with more strength. Therefore, the best candidates for surgery are those with lesions that have a high likelihood of recovery. Factors associated with recovery include being under 65 years old, having had a recent tear, no history of smoking, having an acromiohumeral distance greater than 6 mm, and a Goutallier fatty degeneration grade of less than 2 in the infraspinatus or subscapularis muscles.
A retrospective cohort study investigated the relationship between cervical spine and rotator cuff pathology and confirmed the existence of this relationship.
In a previous study, it was shown that patients with a history of cervical spine issues who underwent shoulder surgery had lower postoperative functional outcomes, lower satisfaction, and higher rates of postoperative complications requiring surgical revision, compared to patients without cervical spine issues. Another study, focusing on a cohort of patients who underwent shoulder surgery, showed that the short-term postoperative outcomes of patients with cervical spine pathology were significantly lower compared to the functional outcomes of patients without cervical spine pathology.
The sample size was calculated using the G*Power 3.1.9.7 program. The logistic regression test was used, with α error set at 0.20 and 80% power. The odds ratio value from Zhang et al.'s (2015) study, titled The Association Between Cervical Spine Pathology and Rotator Cuff Dysfunction, was used as a reference for patients diagnosed with cervical pathology who developed rotator cuff injury or underwent surgery within a five-year period. Based on this value, the required sample size to achieve 80% power was calculated to be 78 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient's who has cervical radiculopathy | – | Other: There was no intervention. Only assessment procedure will be performed.There will be only done assessment. |
| Patient's who has not cervical radiculopathy | – | Other: There was no intervention. Only assessment procedure will be performed.There will be only done assessment. |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted on 50 patients who underwent rotator cuff surgery between 2018 and 2023, with a mean age of 53.74 ± 6.58 years, 54% of whom were female
Key inclusion criteria (2 listed)
- Patients who have undergone rotator cuff repair
- Patients under the age of 65
Key exclusion criteria (7 listed)
- Patients who have undergone shoulder surgery other than rotator cuff repair
- Patients with a history of cervical spine surgery
- Patients with any neurological disorders
- Patients with a history of pathological fractures
- Patients with oncological diseases
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 |
|---|---|---|
| There was no intervention. Only assessment procedure will be performed.There was no intervention. Only assessment procedure will be performed. | Other | Patient's who has cervical radiculopathy, Patient's who has not cervical radiculopathy |
Primary outcome
Functionality and quality of life
Time frame: Between the years 2018 and 2023
1 secondary outcome
pain perception
Time frame: Between the years 2018 and 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Biruni University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ezgisu ören (+905546589732, ezgisuoren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality and quality of life (time frame: Between the years 2018 and 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.