Arthroscopic Shoulder SurgeryPhase 4NCT03738735
Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution
A Phase 4 study testing Hypertonic saline in people with Arthroscopic Shoulder Surgery and Rotator Cuff Tear, run by Rothman Institute Orthopaedics.
Trial summary
The goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery, Rotator Cuff Tear
- What is being tested?
- Hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jun 2020
- Phase
- Phase 4
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years of age
- Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair
The goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.
- Conditions
- Arthroscopic Shoulder Surgery, Rotator Cuff Tear
- Being tested
- Hypertonic saline
- 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.
Hypertonic salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery. |
| Intervention | Experimental | Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery. Receives: Drug: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain rated on scale of 1-10
Measured: daily for 14 days post-operatively
Morphine equivalent
opiod comsumption
Measured: weekly for first 2 weeks post-operatively
Secondary outcomes (3)
American Shoulder Elbow Surgeons standardized shoulder assessment form
shoulder function
Measured: 3 months and 6 months
Passive range of motion
passive range of motion
Measured: 6 weeks, 3 months, 6 months
Active range of motion
Active range of motion
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (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 Arthroscopic Shoulder SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Cox, MD, Principal investigator, Thomas Jefferson UniversityDaniel Davis, MD, Study director, Rothman Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738735
- Sponsor's protocol ID
- 2018Davis
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capito NM, Cook JL, Yahuaca B, Capito MD, Sherman SL, Smith MJ. Safety and efficacy of hyperosmolar irrigation solution in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 May;26(5):745-751. doi: 10.1016/j.jse.2017.02.021. Epub 2017 Mar 18.
PubMed 28318850Capito NM, Smith MJ, Stoker AM, Werner N, Cook JL. Hyperosmolar irrigation compared with a standard solution in a canine shoulder arthroscopy model. J Shoulder Elbow Surg. 2015 Aug;24(8):1243-8. doi: 10.1016/j.jse.2014.12.027. Epub 2015 Feb 25.
PubMed 25725966
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT03738735
- Acronym / sponsor ID
- 2018Davis
- Conditions
- Arthroscopic Shoulder Surgery, Rotator Cuff Tear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Nov 2018 (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 goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery. |
| Intervention | Experimental | Drug: Hypertonic salinePatients will receive hyperosmolar saline for the arthroscopic irrigation during surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years of age
- Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Hypertonic salineFor 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. | Drug | Intervention |
Primary outcome
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
3 secondary outcomes
American Shoulder Elbow Surgeons standardized shoulder assessment form
Time frame: 3 months and 6 months
Passive range of motion
Time frame: 6 weeks, 3 months, 6 months
Active range of motion
Time frame: 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Background: PubMed 28318850Capito NM, Cook JL, Yahuaca B, Capito MD, Sherman SL, Smith MJ. Safety and efficacy of hyperosmolar irrigation solution in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 May;26(5):745-751. doi: 10.1016/j.jse.2017.02.021. Epub 2017 Mar 18.
- Background: PubMed 25725966Capito NM, Smith MJ, Stoker AM, Werner N, Cook JL. Hyperosmolar irrigation compared with a standard solution in a canine shoulder arthroscopy model. J Shoulder Elbow Surg. 2015 Aug;24(8):1243-8. doi: 10.1016/j.jse.2014.12.027. Epub 2015 Feb 25.
- Individual participant dataSharing planned: No
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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.
Ryan Cox, MD principal investigator
Thomas Jefferson University
Daniel Davis, MD study director
Rothman Orthopaedics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypertonic saline in people with Arthroscopic Shoulder Surgery and Rotator Cuff Tear, run by Rothman Institute Orthopaedics.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liam Kane, BS (2673393593, Liam.Kane@rothmanortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: daily for 14 days post-operatively). 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 NCT03738735, 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 13 Nov 2018.