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

Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery

Sponsors

Lead sponsor: Peter Chang

Source University of South Dakota
Brief 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.

Detailed 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.

Overall Status Unknown status
Start Date August 2017
Primary Completion Date December 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Disabilities of the Arm, Shoulder, and Hand Survey (DASH) 1 year
Secondary Outcome
Measure Time Frame
Active Range of Motion of Shoulder Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months
Simple Assessment Numeric Evaluation (SANE) 1 year
Western Ontario Rotator Cuff Survey (WORC) 1 year
Marx Shoulder Activity Level Survey (MARX) 1 year
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: Methylprednisolone (40 mg depomedrol, 1ml, injection)

Description: Experimental Drug

Arm group label: Group B

Intervention type: Drug

Intervention name: Marcaine (4ml 0.5%, injection)

Description: Control

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Jillian Doty

Phone: 888-331-5890

Phone ext: 5579

Email: [email protected]

Location
facility contact investigator
Orthopedic Institute Jillian Doty 888-331-5890 5579 [email protected] Keith M Baumgarten, M.D. Principal Investigator Jillian Doty Sub-Investigator
Location Countries

United States

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of South Dakota

Investigator full name: Peter Chang

Investigator title: Medical Student Researcher

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Group A

Arm group type: Placebo Comparator

Description: After arthroscopic surgery the control group (Group A) will undergo a subacromial marcaine injection (standard of care).

Arm group label: Group B

Arm group type: Experimental

Description: After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov