Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution
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ClinicalTrials.gov Identifier: NCT03738735 |
Recruitment Status : Unknown
Verified November 2018 by Rothman Institute Orthopaedics.
Recruitment status was: Not yet recruiting
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Arthroscopic Shoulder Surgery Rotator Cuff Tear | Drug: Hypertonic saline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair |
Estimated Study Start Date : | January 2019 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
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No Intervention: Control
Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery.
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Experimental: Intervention
Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.
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Drug: Hypertonic saline
For the intervention group, the surgical staff will add 120 mL of 23.4% saline to the 3L bags of lactated Ringer's solution, and this new solution will be used for arthroscopic irrigation purposes throughout the rotator cuff repair surgery. |
- Visual Analogue Scale [ Time Frame: daily for 14 days post-operatively ]pain rated on scale of 1-10
- Morphine equivalent [ Time Frame: weekly for first 2 weeks post-operatively ]opiod comsumption
- American Shoulder Elbow Surgeons standardized shoulder assessment form [ Time Frame: 3 months and 6 months ]shoulder function
- Passive range of motion [ Time Frame: 6 weeks, 3 months, 6 months ]passive range of motion
- Active range of motion [ Time Frame: 3 months, 6 months ]Active range of motion

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age > 18 years of age
Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears
Exclusion Criteria:
Patients younger than 18 years of age
Patients who are pregnant, mentally disabled, or imprisoned
Patients not receiving inter-scalene nerve block (catheters excluded)
Patients undergoing labral repair, capsular release, or distal clavicle excision
Patients with irreparable rotator cuff tears
Patients receiving any repair augmentation or graft
Patients with a known hypersensitivity to sodium lacta

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738735
Contact: Liam Kane, BS | 2673393593 | Liam.Kane@rothmanortho.com | |
Contact: Thema Nicholson | 2673393615 | thema.nicholson@rothmanortho.com |
Principal Investigator: | Ryan Cox, MD | Thomas Jefferson University | |
Study Director: | Daniel Davis, MD | Rothman Orthopaedics |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT03738735 |
Other Study ID Numbers: |
2018Davis |
First Posted: | November 13, 2018 Key Record Dates |
Last Update Posted: | November 13, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries |