Functional Outcomes Following Shoulder Surgery: A Prospective Database

NCT00253864 | Completed Results

• 1 other identifier: 2003658-01H
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.

Conditions

Rotator Cuff Tear

Keywords

shoulder surgery; prospective database; long term outcome

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Index

  The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

  10 year post operative

Secondary Outcomes (3)

• American Shoulder and Elbow Surgeons Score

  10 year post operative

• Constant Score

  10 year post operative

• Strength

  10 year post operative

Study Arms (1)

Arthroscopic rotator cuff repair

Participants who underwent an arthroscopic rotator cuff repair between 2007-2009.

Procedure: Single row; Procedure: Double row

Interventions

Single row PROCEDURE

Fixation type in arthroscopic rotator cuff repair.

Arthroscopic rotator cuff repair

Double row PROCEDURE

Fixation type in arthroscopic rotator cuff repair.

Arthroscopic rotator cuff repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who underwent an arthroscopic rotator cuff surgery between 2007-2009.

You may qualify if:

• arthroscopic rotator cuff repairs that occurred between 2007-2009
• enrolled in previous study comparing single vs double-row fixation

You may not qualify if:

• withdrew from original study
• unable or unwilling to provide written informed consent
• excluded from original study

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Ottawa Hospital Research Institute

kmcilquham@ohri.ca

613-737-8899

Study Officials

• Peter Lapner, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-01

Locations

CA (1)