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Completed

NCT Number: NCT00508183

Types of Fixation in Arthroscopic Rotator Cuff Repair

The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
  • Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion criteria

  • Characteristics of the cuff tear that render the cuff irrepairable.
  • Significant shoulder comorbidities
  • Previous surgery on affected shoulder
  • Patients with active workers compensation claims
  • Active joint or systemic infection
  • Significant muscle paralysis
  • Rotatorcuff tear arthropathy
  • Charcots arthropathy
  • Major medical illness
  • Unable to speak or read English
  • Psychiatric illness that precludes informed consent

Treatment and study plan

Single row

Procedure

This method involves using a single row of anchor(s) to reattach the cuff to the bone.

double row fixation

Procedure

This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.

Primary outcomes

  1. Western Ontario Rotator Cuff Index (WORC)

    Time frame: 2 years

    Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.

Secondary outcomes

  1. Constant Score

    Time frame: 2 Year

    Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function.

  2. ASES Score

    Time frame: 2 Year

    Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function.

  3. Strength Test

    Time frame: 2 Years

    Shoulder strength in forward elevation was measured in kg using a portable scale.

  4. Healing Rate

    Time frame: 1 Year

    Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact).

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2007
Registry last updated
Apr 1, 2020

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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