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Completed

NCT Number: NCT00253864

Functional Outcomes Following Shoulder Surgery: A Prospective Database

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single row

Procedure

Fixation type in arthroscopic rotator cuff repair.

Double row

Procedure

Fixation type in arthroscopic rotator cuff repair.

Primary outcomes

  1. Western Ontario Rotator Cuff Index

    Time frame: 10 year post operative

    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.

Secondary outcomes

  1. American Shoulder and Elbow Surgeons Score

    Time frame: 10 year post operative

    The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.

  2. Constant Score

    Time frame: 10 year post operative

    The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).

  3. Strength

    Time frame: 10 year post operative

    Strength will be measured using a handheld dynamometer in the abduction position which records kilograms of force. The higher the kilogram of force indicates a better result.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Functional Outcome Following Shoulder Surgery: A Prospective Database

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2005
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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