Types of Fixation in Arthroscopic Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508183
• Other study ID #: OHREB2006862-01H
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: July 2011

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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: 10.21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Strength Test	Shoulder strength in forward elevation was measured in kg using a portable scale.	2 Years
Secondary	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