Types of Fixation in Arthroscopic Rotator Cuff Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: single row; Procedure: double row fixation

Detailed Description

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?

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single row fixation	Procedure: single row; This method involves using a single row of anchor(s) to reattach the cuff to the bone.
Active Comparator: double row fixation	Procedure: double row fixation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Rotator Cuff Index (WORC)	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Score	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 Year
ASES Score	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.	2 Year
Strength Test	Shoulder strength in forward elevation was measured in kg using a portable scale.	2 Years
Healing Rate	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).	1 Year

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Peter Lapner, MD, OHRI

Publications and helpful links

General Publications

• Lapner PL, Sabri E, Rakhra K, McRae S, Leiter J, Bell K, Macdonald P. A multicenter randomized controlled trial comparing single-row with double-row fixation in arthroscopic rotator cuff repair. J Bone Joint Surg Am. 2012 Jul 18;94(14):1249-57. doi: 10.2106/JBJS.K.00999.
• Lapner P, Li A, Pollock JW, Zhang T, McIlquham K, McRae S, MacDonald P. A Multicenter Randomized Controlled Trial Comparing Single-Row With Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up. Am J Sports Med. 2021 Sep;49(11):3021-3029. doi: 10.1177/03635465211029029. Epub 2021 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2007
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 25, 2007
• First Submitted That Met QC Criteria: July 26, 2007
• First Posted (Estimate): July 27, 2007

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: full thickness rotator cuff tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: OHREB2006862-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No