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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single row fixation | Active Comparator |
| |
| double row fixation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single row | Procedure | This method involves using a single row of anchor(s) to reattach the cuff to the bone. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lapner, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22810395 | Result | 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. | |
| 34398641 | Derived | 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. |
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Nine patients were never randomized because they either postponed or canceled the surgery, and nineteen patients were excluded prior to randomization for other reasons.
Enrollment occurred from June 2007 to June 2009 at The Ottawa Hospital in Ottawa,Ontario, and the PanAm Clinic in Winnipeg, Manitoba. The target population was men and women of any age with a diagnosis of a full-thickness tear of the rotator cuff according to clinical criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Row Fixation | single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone. |
| FG001 | Double Row Fixation | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Row Fixation | single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone. |
| BG001 | Double Row Fixation | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Row Fixation | single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Lapner | Ottawa Hospital Research Institute | 613-737-8899 | 74700 | plapner@toh.ca |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| 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. |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Ottawa,Ontario Winnipeg, Manitoba | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Year |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Year |
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| Secondary | Strength Test | Shoulder strength in forward elevation was measured in kg using a portable scale. | Posted | Mean | Standard Deviation | kg | 2 Years |
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| 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). | Posted | Number | percentage of patients | 1 Year |
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| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Double Row Fixation | 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. | 0 | 42 | 0 | 42 |
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