NCT00508183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

January 29, 2018

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

July 25, 2007

Results QC Date

April 4, 2017

Last Update Submit

March 25, 2020

Conditions

Rotator Cuff Tear

Keywords

full thickness rotator cuff tear

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Constant Score

    2 Year

  • ASES Score

    2 Year

  • Strength Test

    2 Years

  • Healing Rate

    1 Year

Study Arms (2)

single row fixation

ACTIVE COMPARATOR
Procedure: single row

double row fixation

ACTIVE COMPARATOR
Procedure: double row fixation

Interventions

single rowPROCEDURE

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

single row fixation
double row fixationPROCEDURE

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.

double row fixation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22810395RESULT

  • 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.

    PMID: 34398641DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Results Point of Contact

Title
Dr. Peter Lapner
Organization
Ottawa Hospital Research Institute
plapner@toh.ca
613-737-8899

Study Officials

  • Peter Lapner, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 1, 2020

Results First Posted

January 29, 2018

Record last verified: 2020-03

Locations

CA(1)