Rotator Cuff RepairsNCT07394348
Impact of Rotator Cuff Repair on Rehabilitation Outcome
An observational study of Rotator Cuff Repairs, run by Cairo University.
Trial summary
This study will investigate the difference between BTT (biceps tenotomy ) versus BTD (biceps tenodesis)in patients undergoing rotator cuff repair on postoperative shoulder pain levels, shoulder function, HGS, forearm supination muscle strength, elbow flexion strength Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Repairs
- What is being tested?
- Jamar Handheld dynanometer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to Mar 2027
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 all gender patients with rotator cuff tear , they will be selected based on inclusion criteria and allocated based on type of surgery either combined with long head of biceps tenotomy or tenodesis . They will be grouped according to their surgical intervention by orthopaedic surgeon into 2 cohorts . 25 patients for biceps tenotomy and 25 patients for biceps tenodesis .
Who may be able to join
- The participant's selection will be based on the following criteria:
- Both genders adults diagnosed with ≥ 1-cm full-thickness tears of rotator cuff.
- Age ranged from 50 to 70 years .
- LHB pathology is involved that will receive ARCR combined with biceps tenotomy or tenodesis.
- Arthroscopically confirmed LHB pathology.
- Functionality according to their physical level -
Who cannot join
- Participants will be excluded if they have any of the following criteria:
- Massive irreparable tears.
- Inflammatory arthritis.
- Thyroid disease.
- Glenohumeral osteoarthritis.
- Severe cervical disorders or paralysis of the axillary nerve.
Show all 9Show fewer
- Previous surgery of the affected shoulder.
- Revision surgeries for a rotator cuff tear.
- Complete LHBT rupture. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair
This study will investigate the difference between BTT (biceps tenotomy ) versus BTD (biceps tenodesis)in patients undergoing rotator cuff repair on postoperative shoulder pain levels, shoulder function, HGS, forearm supination muscle strength, elbow flexion strength
Read the detailed description
Rotator cuff tears are common musculoskeletal conditions that are often degenerative and typically affect older adults. They may or may not be symptomatic, and their prevalence increases significantly with age, from approximately 9.7% in individuals under 20 years to 62% in those over 80 years. The rotator cuff plays a critical role in stabilizing the shoulder joint through the concavity-compression mechanism, and its dysfunction can result in shoulder instability, pain, and reduced upper limb strength. Conservative management, including physical therapy, therapeutic modalities, and medications, is considered the first-line approach for treating Rotator cuff tears , while surgical intervention is reserved for cases unresponsive to conservative treatment. Among the commonly performed surgical procedures, biceps tenotomy and biceps tenodesis are often combined with rotator cuff repair to alleviate pain and improve functional outcomes. Hand grip strength is widely recognized as a reliable indicator of overall upper limb function and may be affected by both the pathology and its surgical management. Despite its clinical relevance, limited studies have directly compared the impact of Biceps tenotomy and Biceps tenodesis on Hand grip strength. Furthermore, these surgical techniques may influence other functional outcomes, including elbow flexion strength, forearm supination strength, and pain perception. Therefore, this study seeks to investigate and compare the effects of Biceps tenotomy versus Biceps tenodesis on these parameters in patients undergoing surgical repair for rotator cuff tears.
- Conditions
- Rotator Cuff Repairs
- Being tested
- Jamar Handheld dynanometer
- Keywords
- Biceps tenotomy, Biceps tenodesis, Rehabilitation outcomes, Hand grip strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jamar Handheld dynanometerDevice
is a precision instrument used to measure isometric grip strength. It is widely recognized in clinical research as the "gold standard" for assessing hand strength and general upper-body physical function due to its high test-retest reliability and inter-instrument validity.
| Study group | Role | What they receive |
|---|---|---|
| Biceps tenotomy | Patients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon.
They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenodesis . Receives: Device: Jamar Handheld dynanometer | |
| Biceps tenodesis | Patients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon.
They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenotomy. Receives: Device: Jamar Handheld dynanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Assessed by Visual analog scale : used to assess acute pain particularly effective post-operatively for tracking individual progress .
The patients mark their current pain level on a 100 mm horizontal line anchored by verbal descriptors .
Scoring is : 0 for No symptoms , 10 for very severe symptoms
Measured: 3 time intervals ( pre , within 1 week post , 3 months post )
shoulder function
Will be Assessed by Arabic version of American Shoulder and Elbow Suregeons and Constant Score questionnares * American shoulder and Elbow Surgeons used to evaluate shoulder function and pain .
Patient answer 10 daily activity questions each scored from 0 ( unable) to 3 (normal function ) while the pain assessed by visual analog scale Pain scaore is converted to another 50 point Score total is 100 points ( 50 pain + 50 function ) Higher scores is indication for better shoulder function
- Constant score used to assess shoulder function recovery . It has 2 sections : 1)subjective : 35 points : patient reports on pain and daily activity ability.
2)objective : 65 points : clinical measures for range of motion and strength Grading : pain + activities 0_35 points Range of motion +strength 0_65 points Strength is measured as 1 point per pound lifted for 5 sec ..25 points Score total is 100 points .. The higher is better
Measured: 3 time intervals ( pre , within 1 week post , 3 months post )
Secondary outcomes (3)
Hand grip strength
Will be Assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted .
The highest value obtained will be used for analysis .
Measured: 3 time intervals ( pre , within 1 week post , 3 months post )
Elbow flexion strength
Will be Assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted .
The highest value obtained will be used for analysis .
Measured: 3 time intervals ( pre , within 1 week post , 3 months post )
Forearm supination strength
Will be assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted .
The highest value obtained will be used for analysis .
Measured: 3 time intervals ( pre , within 1 week post , 3 months post )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff RepairsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardin Samuel Nasief, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394348
- Sponsor's protocol ID
- Rehab outcomes in Rotator cuff
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu YC, Huang SW, Adams CR, Lin CY, Chen YP, Kuo YJ, Chuang TY. Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair. J Orthop Surg Res. 2024 Apr 30;19(1):270. doi: 10.1186/s13018-024-04750-8.
PubMed 38689328Aouad D, El Rassi G. Shoulder Arthroscopic Rotator Cuff Repair With Biceps Tenodesis and Acromioplasty Using a Single Working Portal. Arthrosc Tech. 2021 Mar 22;10(4):e1125-e1129. doi: 10.1016/j.eats.2021.01.005. eCollection 2021 Apr.
PubMed 33981560
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07394348
- Acronym / sponsor ID
- Rehab outcomes in Rotator cuff
- Conditions
- Rotator Cuff Repairs
- Keywords
- Biceps tenotomy, Biceps tenodesis, Rehabilitation outcomes, Hand grip strength
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
This study will investigate the difference between BTT (biceps tenotomy ) versus BTD (biceps tenodesis)in patients undergoing rotator cuff repair on postoperative shoulder pain levels, shoulder function, HGS, forearm supination muscle strength, elbow flexion strength
Detailed description
Rotator cuff tears are common musculoskeletal conditions that are often degenerative and typically affect older adults. They may or may not be symptomatic, and their prevalence increases significantly with age, from approximately 9.7% in individuals under 20 years to 62% in those over 80 years. The rotator cuff plays a critical role in stabilizing the shoulder joint through the concavity-compression mechanism, and its dysfunction can result in shoulder instability, pain, and reduced upper limb strength. Conservative management, including physical therapy, therapeutic modalities, and medications, is considered the first-line approach for treating Rotator cuff tears , while surgical intervention is reserved for cases unresponsive to conservative treatment. Among the commonly performed surgical procedures, biceps tenotomy and biceps tenodesis are often combined with rotator cuff repair to alleviate pain and improve functional outcomes. Hand grip strength is widely recognized as a reliable indicator of overall upper limb function and may be affected by both the pathology and its surgical management. Despite its clinical relevance, limited studies have directly compared the impact of Biceps tenotomy and Biceps tenodesis on Hand grip strength. Furthermore, these surgical techniques may influence other functional outcomes, including elbow flexion strength, forearm supination strength, and pain perception. Therefore, this study seeks to investigate and compare the effects of Biceps tenotomy versus Biceps tenodesis on these parameters in patients undergoing surgical repair for rotator cuff tears.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biceps tenotomy | – | Device: Jamar Handheld dynanometerPatients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon. They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenodesis . |
| Biceps tenodesis | – | Device: Jamar Handheld dynanometerPatients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon. They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenotomy. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 all gender patients with rotator cuff tear , they will be selected based on inclusion criteria and allocated based on type of surgery either combined with long head of biceps tenotomy or tenodesis . They will be grouped according to their surgical intervention by orthopaedic surgeon into 2 cohorts . 25 patients for biceps tenotomy and 25 patients for biceps tenodesis .
Key inclusion criteria (6 listed)
- Both genders adults diagnosed with ≥ 1-cm full-thickness tears of rotator cuff.
- Age ranged from 50 to 70 years .
- LHB pathology is involved that will receive ARCR combined with biceps tenotomy or tenodesis.
- Arthroscopically confirmed LHB pathology.
- Functionality according to their physical level -
Key exclusion criteria (9 listed)
- Massive irreparable tears.
- Inflammatory arthritis.
- Thyroid disease.
- Glenohumeral osteoarthritis.
- Severe cervical disorders or paralysis of the axillary nerve.
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 |
|---|---|---|
| Jamar Handheld dynanometeris a precision instrument used to measure isometric grip strength. It is widely recognized in clinical research as the "gold standard" for assessing hand strength and general upper-body physical function due to its high test-retest reliability and inter-instrument validity. | Device | Biceps tenodesis, Biceps tenotomy |
Primary outcome
Pain level
Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )
Assessed by Visual analog scale : used to assess acute pain particularly effective post-operatively for tracking individual progress . The patients mark their current pain level on a 100 mm horizontal line anchored by verbal descriptors . Scoring is : 0 for No symptoms , 10 for very severe symptoms
shoulder function
Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )
Will be Assessed by Arabic version of American Shoulder and Elbow Suregeons and Constant Score questionnares * American shoulder and Elbow Surgeons used to evaluate shoulder function and pain . Patient answer 10 daily activity questions each scored from 0 ( unable) to 3 (normal function ) while the pain assessed by visual analog scale Pain scaore is converted to another 50 point Score total is 100 points ( 50 pain + 50 function ) Higher scores is indication for better shoulder function * Constant score used to assess shoulder function recovery . It has 2 sections : 1)subjective : 35 points : patient reports on pain and daily activity ability. 2)objective : 65 points : clinical measures for range of motion and strength Grading : pain + activities 0_35 points Range of motion +strength 0_65 points Strength is measured as 1 point per pound lifted for 5 sec ..25 points Score total is 100 points .. The higher is better
3 secondary outcomes
Hand grip strength
Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )
Elbow flexion strength
Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )
Forearm supination strength
Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )
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 6 Feb 2026.
- Background: PubMed 38689328Liu YC, Huang SW, Adams CR, Lin CY, Chen YP, Kuo YJ, Chuang TY. Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair. J Orthop Surg Res. 2024 Apr 30;19(1):270. doi: 10.1186/s13018-024-04750-8.
- Background: PubMed 33981560Aouad D, El Rassi G. Shoulder Arthroscopic Rotator Cuff Repair With Biceps Tenodesis and Acromioplasty Using a Single Working Portal. Arthrosc Tech. 2021 Mar 22;10(4):e1125-e1129. doi: 10.1016/j.eats.2021.01.005. eCollection 2021 Apr.
Related trials for Rotator Cuff Repairs
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
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
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Driving After Shoulder Surgery
Shoulder
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Repairs, run by Cairo University.
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 9 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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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?
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 Nardin Samuel Nasief (01212426966, 10722023495578@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 3 time intervals ( pre , within 1 week post , 3 months post )). The study lists 2 primary outcomes in all. 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 NCT07394348, which also lists 2 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 6 Feb 2026.