Functional Outcomes Following Shoulder Surgery: A Prospective Database

NCT ID: NCT00253864

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2020-01-31

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.

Detailed Description

The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results.

For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.

Conditions

Rotator Cuff Tear

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arthroscopic rotator cuff repair

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

Single row

Intervention Type: PROCEDURE

Fixation type in arthroscopic rotator cuff repair.

Double row

Intervention Type: PROCEDURE

Fixation type in arthroscopic rotator cuff repair.

Interventions

Single row

Fixation type in arthroscopic rotator cuff repair.

Intervention Type: PROCEDURE

Double row

Fixation type in arthroscopic rotator cuff repair.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2003658-01H

Identifier Type: -

Identifier Source: org_study_id