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Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT02867904
Recruitment Status : Unknown
Verified August 2016 by Peter Chang, University of South Dakota.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Peter Chang, 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.

Condition or disease Intervention/treatment Phase
Arthroscopic Shoulder Surgery Intra-articular Debridement Subacromial Decompression Acromioplasty Acromioclavicular Joint Resection Drug: Methylprednisolone (40 mg depomedrol, 1ml, injection) Drug: Marcaine (4ml 0.5%, injection) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery
Study Start Date : August 2017
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Placebo Comparator: Group A
After arthroscopic surgery the control group (Group A) will undergo a subacromial marcaine injection (standard of care).
Drug: Marcaine (4ml 0.5%, injection)
Control

Experimental: Group B
After arthroscopic surgery the experimental group (Group B) will undergo a subacromial corticosteroid injection+marcaine.
Drug: Methylprednisolone (40 mg depomedrol, 1ml, injection)
Experimental Drug

Drug: Marcaine (4ml 0.5%, injection)
Control




Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder, and Hand Survey (DASH) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Active Range of Motion of Shoulder [ Time Frame: Pre-operatively and Post-operatively at 2 weeks, 6 weeks, and 3 months ]
    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

  2. Simple Assessment Numeric Evaluation (SANE) [ Time Frame: 1 year ]
  3. Western Ontario Rotator Cuff Survey (WORC) [ Time Frame: 1 year ]
  4. Marx Shoulder Activity Level Survey (MARX) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT02867904


Contacts
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Contact: Jillian Doty 888-331-5890 ext 5579 JDoty@ortho-i.com

Locations
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United States, South Dakota
Orthopedic Institute Not yet recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Jillian Doty    888-331-5890 ext 5579    JDoty@ortho-i.com   
Principal Investigator: Keith M Baumgarten, M.D.         
Sub-Investigator: Jillian Doty         
Sponsors and Collaborators
Peter Chang

Publications:

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Responsible Party: Peter Chang, Medical Student Researcher, University of South Dakota
ClinicalTrials.gov Identifier: NCT02867904     History of Changes
Other Study ID Numbers: 2016.128
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents