Clinical trial NCT03797287: Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
Official title: Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Pain Chronic
Shoulder Pain
Rotator Cuff Tear
Rotator Cuff Injury
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.

Detailed description: Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.

Study Procedures:

Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:

Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.

Patient Visits:

Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op.

An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.

Eligibility criteria: Inclusion Criteria:

* Adults age 18-75 years old
* Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
* Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)

Exclusion Criteria:

* Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
* Patients undergoing revision rotator cuff tears will be excluded.

Primary outcomes:
measure: Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
timeFrame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Secondary outcomes:
measure: Change in shoulder pain as assessed by Visual Analog Pain Score
timeFrame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
measure: Change in Range of Motion (ROM)
timeFrame: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year
measure: Change in Strength Testing
timeFrame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
measure: Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index
timeFrame: Before surgery, 1 year after surgery, 2 years after surgery
measure: Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)
timeFrame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
measure: Implant Cost
timeFrame: Within 1 month after surgery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Uma Srikumaran, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: