Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery

Arthroscopic Shoulder Surgery Clinical Trial

Official title:

Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02867904
• Other study ID #: 2016.128
• Status: Terminated
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: April 2020

Study information

• Verified date: May 2021
• Source: University of South Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of intra-operative subacromial corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of life scores and activity level when compared to a control group.

Description:

This study is designed to assess whether a subacromial injection of corticosteroids at the time of arthroscopic shoulder surgery influences quality of life scores and activity level when compared to a control group. The hypothesis is that intra-operative subacromial corticosteroid injection after arthroscopic subacromial decompression surgery will provide a more rapid improvement in quality of life scores and activity levels in the post-operative period compared with controls. The study will be a placebo-controlled, double-blind prospective study. All patients necessitating arthroscopic shoulder surgery presenting to Dr. Keith Baumgarten's clinics are eligible for participation. If the patient meets the inclusion criteria, then informed consent will be obtained for participation in this study. Each patient will undergo a standard shoulder exam to assess active range of motion and complete demographics and pre-operative patient determined outcomes surveys (1. Disabilities of the Arm, Shoulder, and Hand (DASH) 2. Simple Assessment Numeric Evaluation (SANE) 3. Western Ontario Rotator Cuff (WORC)) and the Marx shoulder activity level survey (MARX). Patients will then undergo arthroscopic shoulder surgery. After arthroscopic surgery the experimental group will undergo a subacromial corticosteroid injection + marcaine while the control group will undergo a subacromial marcaine injection. Outcomes will be assessed using the same quality of life surveys and an activity level survey at post-operative visits at the time intervals: 2 weeks and 3 months and by U.S. mail at 5 months and 1 year. Active range of motion will be assessed at post-operative visits: 2 weeks, 6 weeks, and 3 months. Subjects that meet criteria to undergo arthroscopic shoulder surgery will be provided informed consent to receiving either a subacromial corticosteroid injection or placebo injection at the end of surgery. Patients will be expected to complete all pre- and post-operative quality of life surveys and activity level surveys. It will take less than 20 minutes to complete all listed surveys at each pre- and post-operative visit. Active range of motion will be assessed at each post-operative visit and subjects will be expected to take part in this physical examination as well. The duration of subject participation is 1 year from the date of initial surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years-old or older

• Male patients

• Female patients

• Patients able to speak and understand written English

• Patients presenting to the orthopedic institute clinic with shoulder pain and necessitating the procedure of arthroscopic shoulder surgery

• Specific arthroscopic procedures include: intra-articular debridement, decompression, acromioplasty, and acromioclavicular joint resection

Exclusion Criteria:

• Patients undergoing arthroscopic shoulder surgery that includes other interventions (i.e. rotator cuff repair; labral repair, etc)

• Patients with adhesive capsulitis

• Patients with significant cervical spine symptoms and/or pathology

• Patients having a history of receiving chronic pain treatment

• Patients who are currently pregnant or who become pregnant before surgery

• Patients who cannot speak or understand written english

• Patients who are under the age of 18 years of age

• As per exclusionary criteria if a subject is pregnant they will not be eligible for participation.

Related Conditions & MeSH terms

• Acromioclavicular Joint Resection
• Acromioplasty
• Arthroscopic Shoulder Surgery
• Intra-articular Debridement
• Subacromial Decompression

Intervention

Drug:
• Methylprednisolone (40 mg depomedrol, 1ml, injection)
Experimental Drug
• Marcaine (4ml 0.5%, injection)
Control

Locations

Country	Name	City	State
United States	Orthopedic Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Peter Chang

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Cancienne JM, Gwathmey FW, Werner BC. Intraoperative Corticosteroid Injection at the Time of Knee Arthroscopy Is Associated With Increased Postoperative Infection Rates in a Large Medicare Population. Arthroscopy. 2016 Jan;32(1):90-5. doi: 10.1016/j.arthro.2015.09.003. Epub 2015 Nov 6. — View Citation

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Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20. — View Citation

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Westermann RW, Pugely AJ, Ries Z, Amendola A, Martin CT, Gao Y, Wolf BR. Causes and Predictors of 30-Day Readmission After Shoulder and Knee Arthroscopy: An Analysis of 15,167 Cases. Arthroscopy. 2015 Jun;31(6):1035-1040.e1. doi: 10.1016/j.arthro.2015.03.029. — View Citation

Zheng XQ, Li K, Wei YD, Tie HT, Yi XY, Huang W. Nonsteroidal anti-inflammatory drugs versus corticosteroid for treatment of shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Oct;95(10):1824-31. doi: 10.1016/j.apmr.2014.04.024. Epub 2014 May 16. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder, and Hand Survey (DASH)		1 year
Secondary	Active Range of Motion of Shoulder	Change from baseline active range of motion will be assessed. Range of motion of the shoulder joint will be examined by having the patient actively flex, extend, abduct, adduct, internally rotate, and externally rotate the shoulder	Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months
Secondary	Simple Assessment Numeric Evaluation (SANE)		1 year
Secondary	Western Ontario Rotator Cuff Survey (WORC)		1 year
Secondary	Marx Shoulder Activity Level Survey (MARX)		1 year