Rotator Cuff Injury to Surgery

NCT01744080 | Withdrawn

• 1 other identifier: B2012:112
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized controlled trial is to compare post-operative outcome between participants undergoing expedited surgery compared to those proceeding through a 'typical' wait time process. A secondary purpose is to evaluate the progression of rotator cuff tear size from the time of initial consult to the time of surgery.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff

  WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate

  24 months

Secondary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES)

  24 months

Other Outcomes (1)

• Injury to Surgery Time

  24 months

Study Arms (2)

Early Surgery

ACTIVE COMPARATOR

Other: Early Surgery

Regular Wait Time

EXPERIMENTAL

Other: Regular Wait Time

Interventions

Regular Wait Time OTHER

Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.

Regular Wait Time

Early Surgery OTHER

Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.

Early Surgery

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 45 and 70 years old
• Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)

You may not qualify if:

• Presence of a tear of the subscapularis and/or teres minor;
• Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
• Patient has undergone previous RC surgery to the affected shoulder;
• Patient has an active WCB Claim or prior claim related to their shoulder;
• Previous major joint trauma, infection, or avascular necrosis;
• Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
• Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
• Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
• Major medical illness where life expectancy is less than 2 years;
• Does not speak/read/understand English;
• No fixed address or means of contact;
• Unwillingness to complete necessary follow-ups

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M3E4, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Jeff Leiter, MSc, PhD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head, Orthopaedics

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

CA (1)