Surgical Management of Irreparable RC Tears

Rotator Cuff Tear Clinical Trial

Official title:

Surgical Treatment of Massive and Irreparable Rotator Cuff Tears

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03878862
• Other study ID #: H2018:135
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Panam Clinic
• Contact: Sheila McRae, PhD
• Phone: 204-925-7469
• Email: smcrae[@]panamclinic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

Description:

Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.

Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.

Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.

Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.

• Definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus

Exclusion criteria:

• Protected populations: prisoners, military, non-English speakers, age <18 years

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Locations

Country	Name	City	State
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Panam Clinic	Pan Am Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale for pain	10 cm scale with 0 = no pain and 10= extreme pain	24-months
Primary	Simple shoulder test	A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12	24-months
Primary	American Shoulder and Elbow Score	Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome	24-months
Primary	Veterans Rand - 12	A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.	24-months
Primary	Western Ontario Rotator Cuff score	A validated measure with 0 as a poor score and 100 as a positive score.	24-months