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| Name | Class |
|---|---|
| Musculoskeletal Transplant Foundation | OTHER |
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This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Row | Experimental | Double Row |
|
| Double Row with PRFM | Experimental | Double Row with PRFM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRFM | Device |
| ||
| Double Row |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Baseline |
| Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | 6 months |
| Return to Function | Western Ontario Rotator Cuff Index | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Spraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | Baseline |
| MRI |
Inclusion Criteria:
Exclusion Criteria:
Pre-operative exclusion criteria
Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Row | Double Row Double Row |
| FG001 | Double Row With PRFM | Double Row with PRFM PRFM Double Row |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double Row Only | Double Row |
| BG001 | Double Row With PRFM | PRFM |
| BG002 |
| 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 | Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
24 month
24 month visit
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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 | Double Row | Double Row Double Row |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oncological | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Cancer |
A disadvantage is the majority of the tears are small or medium sized. These have a higher intrinsic healing and as such may not require platelet augmentation to afford a successful outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Walsh | Health Partners | (952) 831-8742 | michael.walsh@tria.com |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D020069 | Shoulder Pain |
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D018771 | Arthralgia |
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|
MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes. |
| 6 months |
| Supraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | 6 months |
| Supraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | 24 months |
| Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | Baseline |
| Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | 6 months |
| Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | 24 months |
| Physician Decision |
|
| Screen Fail |
|
| Equipment Malfunction |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Primary | Return to Function | Western Ontario Rotator Cuff Index | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Other Pre-specified | Spraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | Baseline |
|
|
|
| Other Pre-specified | MRI | MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| Other Pre-specified | Supraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | 6 months |
|
|
|
| Other Pre-specified | Supraspinatus Strength Measurements | Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | 24 months |
|
|
|
| Other Pre-specified | Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | Baseline |
|
|
|
| Other Pre-specified | Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | 6 months |
|
|
|
| Other Pre-specified | Infraspinatus Strength Measurements | Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100. | There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Posted | Mean | Standard Deviation | percentage of uninvolved | 24 months |
|
|
|
| 0 |
| 55 |
| 9 |
| 55 |
| EG001 | Double Row With PRFM | Double Row with PRFM PRFM Double Row | 0 | 42 | 2 | 42 |
|
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Optomological | Eye disorders | Non-systematic Assessment |
|
| ENT | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Urinary | Renal and urinary disorders | Non-systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Endocrine | Endocrine disorders | Non-systematic Assessment |
|
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |