Rotator Cuff TearsNCT05721547
Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tears and Posture, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Posture, Spinal Curvatures
- What is being tested?
- Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2018to 15 Jan 2020
- How long will I take part?
- 8 Months
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent arthroscopic RM surgery who had undergone the same arthroscopic RM surgical procedure and technique
Who may be able to join
- those who had undergone the same arthroscopic RM surgical procedure and technique
- had undergone acromioplasty and/or tenodesis with RM repair
- had undergone arthroscopic RM surgery from the upper extremity of the dominant side;
- had completed six months following surgery; were able to perform active shoulder elevation movements of 90° or more
- were between the ages of 40 and 75
- were volunteers to participate in the study.
Who cannot join
- who had undergone previous shoulder surgery or revision surgery, subscapularis tendon repair in addition to RM repair, scoliosis surgery, or any surgeries to limit spine motion, as well as those with a history of upper extremity fractures, diabetes mellitus, hypertension, cardiovascular disease, or chronic respiratory diseases that could limit the test's ability to be accomplished
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, Central, 14000
About this study
Official title: Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair: Which Factors Differ From Healthy Individuals?
The aim of this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.
Read the detailed description
Shoulder dysfunctions are thought to be predisposed by poor posture and muscle imbalances. The shoulder functionality could be limited or worsened by a restricted range of motion (ROM) of the spine. Evidence from studies evaluating both people with shoulder pain and asymptomatic participants indicates a relationship between a decreased thoracic kyphosis and an increased shoulder ROM. Therefore, a higher thoracic kyphosis may be linked to a lower ROM in the shoulder. Shoulder dysfunction becomes more common after the age of 40, and the relationship between spinal posture and shoulder dysfunction is crucially needed to be assessed.
The aim of this observational study was to the alterations in spinal alignment and mobility in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.
This cross-sectional observational study was conducted with patients who underwent arthroscopic RM surgery and healthy volunteers.
- Conditions
- Rotator Cuff Tears, Posture, Spinal Curvatures, Arthroscopic Surgery
- Being tested
- Assessment
- Medical subject headings
- Rotator Cuff Injuries, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Assessment
| Study group | Role | What they receive |
|---|---|---|
| RC Repair Group | Participants who had undergone the same arthroscopic RM surgical procedure and technique; had undergone acromioplasty and/or tenodesis with RM repair; had undergone arthroscopic RM surgery from the upper extremity of the dominant side; had completed six months following surgery Receives: Other: Assessment | |
| Healthy Group | Participants who had not undergone any shoulder surgery, had no history of shoulder-related pain, discomfort, or trauma in the last year Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal alignment and mobility assessment
The Spinal Mouse (IDIAG M360), novel, a computer-aided electronic measuring tool that noninvasively evaluates spinal range of motion and intersegmental angles, was used to examine spinal posture. The Spinal Mouse device is reliable and valid for the assessment of spine mobility and posture
Measured: 8 months
Secondary outcomes (3)
Scapular dyskinesia
Performed using the observational scapular dyskinesia test
Measured: 8 months
Range of Motion
Performed using with Goniometer
Measured: 8 months
Postural stability
Performed using with functional reach test
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Jun 2018
- Primary completion25 May 2019
- Study completion15 Jan 2020
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 Abant Izzet Baysal 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Yazgan Dagli, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721547
- Sponsor's protocol ID
- AIBU-FTR-BYD-02
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair: Which Factors Differ From Healthy Individuals?
- ClinicalTrials.gov ID
- NCT05721547
- Acronym / sponsor ID
- AIBU-FTR-BYD-02
- Conditions
- Rotator Cuff Tears, Posture, Spinal Curvatures, Arthroscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 10 Feb 2023 (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 this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.
Detailed description
Shoulder dysfunctions are thought to be predisposed by poor posture and muscle imbalances. The shoulder functionality could be limited or worsened by a restricted range of motion (ROM) of the spine. Evidence from studies evaluating both people with shoulder pain and asymptomatic participants indicates a relationship between a decreased thoracic kyphosis and an increased shoulder ROM. Therefore, a higher thoracic kyphosis may be linked to a lower ROM in the shoulder. Shoulder dysfunction becomes more common after the age of 40, and the relationship between spinal posture and shoulder dysfunction is crucially needed to be assessed.
The aim of this observational study was to the alterations in spinal alignment and mobility in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.
This cross-sectional observational study was conducted with patients who underwent arthroscopic RM surgery and healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC Repair Group | – | Other: AssessmentParticipants who had undergone the same arthroscopic RM surgical procedure and technique; had undergone acromioplasty and/or tenodesis with RM repair; had undergone arthroscopic RM surgery from the upper extremity of the dominant side; had completed six months following surgery |
| Healthy Group | – | Other: AssessmentParticipants who had not undergone any shoulder surgery, had no history of shoulder-related pain, discomfort, or trauma in the last year |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent arthroscopic RM surgery who had undergone the same arthroscopic RM surgical procedure and technique
Key inclusion criteria (6 listed)
- those who had undergone the same arthroscopic RM surgical procedure and technique
- had undergone acromioplasty and/or tenodesis with RM repair
- had undergone arthroscopic RM surgery from the upper extremity of the dominant side;
- had completed six months following surgery; were able to perform active shoulder elevation movements of 90° or more
- were between the ages of 40 and 75
Key exclusion criteria (1 listed)
- who had undergone previous shoulder surgery or revision surgery, subscapularis tendon repair in addition to RM repair, scoliosis surgery, or any surgeries to limit spine motion, as well as those with a history of upper extremity fractures, diabetes mellitus, hypertension, cardiovascular disease, or chronic respiratory diseases that could limit the test's ability to be accomplished
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 |
|---|---|---|
| AssessmentAssessment | Other | Healthy Group, RC Repair Group |
Primary outcome
Spinal alignment and mobility assessment
Time frame: 8 months
The Spinal Mouse (IDIAG M360), novel, a computer-aided electronic measuring tool that noninvasively evaluates spinal range of motion and intersegmental angles, was used to examine spinal posture. The Spinal Mouse device is reliable and valid for the assessment of spine mobility and posture
3 secondary outcomes
Scapular dyskinesia
Time frame: 8 months
Range of Motion
Time frame: 8 months
Postural stability
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
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.
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 and Posture, run by Abant Izzet Baysal 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 6 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: finished, as of the sponsor's last update on 10 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spinal alignment and mobility assessment (time frame: 8 months). 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 10 Feb 2023.