Rotator Cuff TearNCT07327437
Arthroscopic Trans-osseous Rotator-Cuff Repair Using the Giant-Needle and Grand-Knot Technique.
A study testing Grand-Knot Technique and All-Suture Anchors (Y-Knot RC) in people with Rotator Cuff Tear, run by Sherif Hamdy Zawam at 1 site in Egypt.
Trial summary
The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Grand-Knot Technique and All-Suture Anchors (Y-Knot RC)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jul 2025
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 45 to 75 years.
- Diagnosis of full-thickness supraspinatus or posterosuperior rotator-cuff tears.
- Tears suitable for arthroscopic repair.
- Confirmation of diagnosis and tear morphology via standardized clinical examination and MRI.
- Willingness to comply with a 2.5-year follow-up protocol and standardized rehabilitation.
Who cannot join
- Partial-thickness tears or isolated subscapularis tears.
- Advanced fatty infiltration (Fuchs grade 3-4).
- Rotator cuff arthropathy (Hamada classification > 2).
- Presence of calcific tendinitis in the affected shoulder.
- Prior ipsilateral shoulder surgery.
- General medical contraindications to arthroscopy or general anesthesia.
- Inability to complete the follow-up or provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. The study evaluates which method provides better functional recovery and structural healing for patients with full-thickness supraspinatus tears. Patients were randomized to receive either the Grand-Knot repair or the standard anchor repair and were followed for a minimum of 2.5 years to assess shoulder function using the ASES score, range of motion, and tendon integrity."
Read the detailed description
"This prospective randomized comparative study was designed to evaluate the clinical and biomechanical effectiveness of an anchorless trans-osseous repair for rotator cuff tears.
Participants: 160 patients (aged 45-75) with full-thickness supraspinatus or posterosuperior tears were enrolled.
Interventions: > 1. Experimental Group: The Grand-Knot technique utilized a 'Giant Needle' to create trans-osseous tunnels, through which sutures were passed and secured using a specialized suture-block (Grand-Knot) on the lateral cortex. 2. Control Group: Standard arthroscopic repair was performed using 2.8 mm all-suture anchors (Y-Knot RC).
Procedure: All surgeries were performed arthroscopically by a single senior surgeon. Postoperative rehabilitation was standardized for both groups.
Outcomes: The primary endpoint was the American Shoulder and Elbow Surgeons (ASES) score at 30 months. Secondary endpoints included the Constant score, objective range of motion (ROM) measured by a goniometer, and structural integrity of the tendon as assessed by postoperative MRI or ultrasound at 6 months. Additionally, the study incorporates biomechanical data comparing the load-to-failure strength of both constructs."
- Conditions
- Rotator Cuff Tear
- Being tested
- Grand-Knot Technique, All-Suture Anchors (Y-Knot RC)
- Keywords
- Rotator cuff, Transosseous, Giant needle, Grand Knot
- 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.
Grand-Knot TechniqueProcedure or surgery
Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot).
All-Suture Anchors (Y-Knot RC)Device
Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint.
| Study group | Role | What they receive |
|---|---|---|
| Grand-Knot Group | Experimental | Patients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique. Receives: Procedure: Grand-Knot Technique |
| Suture Anchor Group | Active comparator | Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors. Receives: Device: All-Suture Anchors (Y-Knot RC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons ASES Score
The ASES score is a standardized clinician-completed and patient-reported instrument consisting of two sections: pain (50%) and activities of daily living (50%). The total score ranges from 0 to 100, where 100 indicates the best possible shoulder function and 0 indicates the worst.
Measured: 30 months (2.5 years) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, two-arm, parallel-group randomized comparative study. Participants were allocated to either the Experimental Group (arthroscopic trans-osseous repair using the 'Grand-Knot' suture-block technique) or the Active Comparator Group (arthroscopic repair using all-suture anchors) in a 1:1 ratio. Randomization was achieved via a computer-generated sequence. Allocation concealment was maintained using sequentially numbered, sealed opaque envelopes opened by an independent assistant only after the intraoperative confirmation of tear morphology. Both groups followed an identical, standardized postoperative rehabilitation protocol and were assessed at predetermined intervals up to 30 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif Hamdy Zawam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif Hamdy Zawam, Cairo University
- Investigators
- Sherif Zawam, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327437
- Sponsor's protocol ID
- IRB: 11625-442021
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data has not yet been finalized. Access to de-identified data may be considered upon reasonable request to the Principal Investigator, subject to approval by the Cairo University Faculty of Medicine Research Ethics Committee and in accordance with institutional data privacy policies.
Publications
Park MC, ElAttrache NS, Tibone JE, Ahmad CS, Jun BJ, Lee TQ. Part I: Footprint contact characteristics for a transosseous-equivalent rotator cuff repair technique compared with a double-row repair technique. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):461-8. doi: 10.1016/j.jse.2006.09.010. Epub 2007 Feb 22.
PubMed 17321161Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
PubMed 22958838Dines JS, et al. Biomechanical comparison of all-suture anchors and traditional rigid anchors. Arthroscopy. 2016.
Author et al. Arthroscopic trans-osseous rotator cuff repair using the Grand-Knot technique: A technical note. Journal Name. Year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Trans-osseous Rotator-Cuff Repair Using the Giant-Needle and Grand-Knot Technique.
- ClinicalTrials.gov ID
- NCT07327437
- Acronym / sponsor ID
- IRB: 11625-442021
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff, Transosseous, Giant needle, Grand Knot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sherif Hamdy ZawamUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 8 Jan 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.
The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. The study evaluates which method provides better functional recovery and structural healing for patients with full-thickness supraspinatus tears. Patients were randomized to receive either the Grand-Knot repair or the standard anchor repair and were followed for a minimum of 2.5 years to assess shoulder function using the ASES score, range of motion, and tendon integrity."
Detailed description
"This prospective randomized comparative study was designed to evaluate the clinical and biomechanical effectiveness of an anchorless trans-osseous repair for rotator cuff tears.
Participants: 160 patients (aged 45-75) with full-thickness supraspinatus or posterosuperior tears were enrolled.
Interventions: > 1. Experimental Group: The Grand-Knot technique utilized a 'Giant Needle' to create trans-osseous tunnels, through which sutures were passed and secured using a specialized suture-block (Grand-Knot) on the lateral cortex. 2. Control Group: Standard arthroscopic repair was performed using 2.8 mm all-suture anchors (Y-Knot RC).
Procedure: All surgeries were performed arthroscopically by a single senior surgeon. Postoperative rehabilitation was standardized for both groups.
Outcomes: The primary endpoint was the American Shoulder and Elbow Surgeons (ASES) score at 30 months. Secondary endpoints included the Constant score, objective range of motion (ROM) measured by a goniometer, and structural integrity of the tendon as assessed by postoperative MRI or ultrasound at 6 months. Additionally, the study incorporates biomechanical data comparing the load-to-failure strength of both constructs."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, two-arm, parallel-group randomized comparative study. Participants were allocated to either the Experimental Group (arthroscopic trans-osseous repair using the 'Grand-Knot' suture-block technique) or the Active Comparator Group (arthroscopic repair using all-suture anchors) in a 1:1 ratio. Randomization was achieved via a computer-generated sequence. Allocation concealment was maintained using sequentially numbered, sealed opaque envelopes opened by an independent assistant only after the intraoperative confirmation of tear morphology. Both groups followed an identical, standardized postoperative rehabilitation protocol and were assessed at predetermined intervals up to 30 months.
| Arm | Type | Receives |
|---|---|---|
| Grand-Knot Group | Experimental | Procedure: Grand-Knot TechniquePatients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique. |
| Suture Anchor Group | Active comparator | Device: All-Suture Anchors (Y-Knot RC)Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 45 to 75 years.
- Diagnosis of full-thickness supraspinatus or posterosuperior rotator-cuff tears.
- Tears suitable for arthroscopic repair.
- Confirmation of diagnosis and tear morphology via standardized clinical examination and MRI.
- Willingness to comply with a 2.5-year follow-up protocol and standardized rehabilitation.
Key exclusion criteria (7 listed)
- Partial-thickness tears or isolated subscapularis tears.
- Advanced fatty infiltration (Fuchs grade 3-4).
- Rotator cuff arthropathy (Hamada classification > 2).
- Presence of calcific tendinitis in the affected shoulder.
- Prior ipsilateral shoulder surgery.
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 |
|---|---|---|
| Grand-Knot TechniqueUse of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot). | Procedure or surgery | Grand-Knot Group |
| All-Suture Anchors (Y-Knot RC)Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint. | Device | Suture Anchor Group |
Primary outcome
American Shoulder and Elbow Surgeons ASES Score
Time frame: 30 months (2.5 years) postoperatively
The ASES score is a standardized clinician-completed and patient-reported instrument consisting of two sections: pain (50%) and activities of daily living (50%). The total score ranges from 0 to 100, where 100 indicates the best possible shoulder function and 0 indicates the worst.
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 8 Jan 2026.
- Background: PubMed 17321161Park MC, ElAttrache NS, Tibone JE, Ahmad CS, Jun BJ, Lee TQ. Part I: Footprint contact characteristics for a transosseous-equivalent rotator cuff repair technique compared with a double-row repair technique. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):461-8. doi: 10.1016/j.jse.2006.09.010. Epub 2007 Feb 22.
- Background: PubMed 22958838Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
- BackgroundDines JS, et al. Biomechanical comparison of all-suture anchors and traditional rigid anchors. Arthroscopy. 2016.
- BackgroundAuthor et al. Arthroscopic trans-osseous rotator cuff repair using the Grand-Knot technique: A technical note. Journal Name. Year.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data has not yet been finalized. Access to de-identified data may be considered upon reasonable request to the Principal Investigator, subject to approval by the Cairo University Faculty of Medicine Research Ethics Committee and in accordance with institutional data privacy policies.
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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.
Sherif Zawam, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grand-Knot Technique and All-Suture Anchors (Y-Knot RC) in people with Rotator Cuff Tear, run by Sherif Hamdy Zawam at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 8 Jan 2026. 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 Egypt. 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?
American Shoulder and Elbow Surgeons ASES Score (time frame: 30 months (2.5 years) postoperatively). 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 NCT07327437, which also lists 4 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 8 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.