Rotator Cuff TearsNCT04388306
Shoulder Functional Performance After Shoulder Surgery
An observational study of Rotator Cuff Tears, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period. Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2018to 16 Jan 2019
- How long will I take part?
- 4 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group consists of participants with undergone arthroscopic RC repair at Bolu Abant İzzet Baysal University, Department of Orthopedics and Traumatology.
Who may be able to join
- With the same RC surgical procedure and technique,
- With acromioplasty and/or tenodesis with RC repair,
- Undergoing arthroscopic RC repair from the upper extremity of the dominant side,
- Having completed the 12th week after surgery,
- Performing 90° and above active shoulder elevation movement
Who cannot join
- Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity
- Having undergone surgery causing limitation of motion in the spine,
- Having a neurological and/or vestibular and/or rheumatologic disease,
- Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test
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: Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors
Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.
Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.
Read more
Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.
Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.
Read the detailed description
Design: observational Cross-sectional study.
- Conditions
- Rotator Cuff Tears
- Being tested
- Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)Other
Also called Shoulder Functionality-Modified Constant Murley Score, Scapular Endurance-Scapular Muscle Endurance Test, Strength-Total Upper Extremity Muscle Strength
Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Thirty-two participants with undergone arthroscopic Rotator Cuff repair Receives: Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA) | |
| Control Group | Thirty-two healthy participants Receives: Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.
Measured: Three months
Secondary outcomes (3)
Modified Constant Murley Score
Shoulder functionality was analyzed by using the MCMS evaluating pain, daily living activities, ROM and strength. Pain was evaluated by visual analog scale and ROM by goniometer. The force in the shoulder abduction position was measured with the Digital analyzer defined by the spring balance technique.
Measured: Three months
Scapular Muscle Endurance Test
The scapular muscle endurance test evaluate the endurance of the serratus anterior and the trapezium muscles.
Measured: Three months
Total Upper Extremity Muscle Strength
Total upper extremity muscle strength was evaluated with Jamar hand dynamometer. Grip strength is considered to be a valid value of TUEMS. The test was performed by measuring both sides.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start12 Jun 2018
- Primary completion25 Dec 2018
- Study completion16 Jan 2019
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 4 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
- Investigators
- Beyza YAZGAN DAĞLI, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388306
- Sponsor's protocol ID
- AIBU-FTR-BYD-01
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors
- ClinicalTrials.gov ID
- NCT04388306
- Acronym / sponsor ID
- AIBU-FTR-BYD-01
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 14 May 2020 (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.
Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.
Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.
Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.
Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.
Detailed description
Design: observational Cross-sectional study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)Thirty-two participants with undergone arthroscopic Rotator Cuff repair |
| Control Group | – | Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)Thirty-two healthy participants |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group consists of participants with undergone arthroscopic RC repair at Bolu Abant İzzet Baysal University, Department of Orthopedics and Traumatology.
Key inclusion criteria (5 listed)
- With the same RC surgical procedure and technique,
- With acromioplasty and/or tenodesis with RC repair,
- Undergoing arthroscopic RC repair from the upper extremity of the dominant side,
- Having completed the 12th week after surgery,
- Performing 90° and above active shoulder elevation movement
Key exclusion criteria (4 listed)
- Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity
- Having undergone surgery causing limitation of motion in the spine,
- Having a neurological and/or vestibular and/or rheumatologic disease,
- Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test
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 |
|---|---|---|
| Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)Also: Shoulder Functionality-Modified Constant Murley Score, Scapular Endurance-Scapular Muscle Endurance Test, Strength-Total Upper Extremity Muscle StrengthParticipants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test. | Other | Control Group, Study Group |
Primary outcome
Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
Time frame: Three months
FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.
3 secondary outcomes
Modified Constant Murley Score
Time frame: Three months
Scapular Muscle Endurance Test
Time frame: Three months
Total Upper Extremity Muscle Strength
Time frame: Three 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 14 May 2020.
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Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
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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.
Beyza YAZGAN DAĞLI principal investigator
Abant Izzet Baysal University
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 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 5 inclusion and 4 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 14 May 2020. 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?
Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA) (time frame: Three 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 14 May 2020.