Types of Fixation in Arthroscopic Rotator Cuff Repair

• ClinicalTrials.gov Identifier: NCT00508183
• Recruitment Status: Completed
• First Posted: July 27, 2007
• Results First Posted: January 29, 2018
• Last Update Posted: April 1, 2020
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear	Procedure: single row; Procedure: double row fixation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.
• Actual Study Start Date: June 2007
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1Y 4E9

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Peter Lapner, MD; OHRI

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT00508183
• Other Study ID Numbers: OHREB2006862-01H
• First Posted: July 27, 2007
• Results First Posted: January 29, 2018
• Last Update Posted: April 1, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

full thickness rotator cuff tear

Additional relevant MeSH terms:

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