Rotator Cuff Tear
Conditions
Keywords
Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury
Brief summary
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.
Interventions
DEVICEPRFM
PROCEDUREDouble Row
Sponsors
Musculoskeletal Transplant Foundation
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI) * Patient undergoes arthroscopic rotator cuff repair * Age 18 or older
Exclusion criteria
Pre-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to Function | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Spraspinatus Strength Measurements | Baseline | 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. |
| MRI | 6 months | 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. |
| Supraspinatus Strength Measurements | 6 months | 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. |
| Infraspinatus Strength Measurements | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double Row Only Double Row | 55 |
| Double Row With PRFM PRFM | 42 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Equipment Malfunction | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Physician Decision | 7 | 3 |
| Overall Study | Screen Fail | 5 | 4 |
Baseline characteristics
| Characteristic | Double Row Only | Total | Double Row With PRFM |
|---|---|---|---|
| Age, Continuous | 53.00 years | 56.15 years | 58.64 years |
| Region of Enrollment United States | 55 participants | 97 participants | 42 participants |
| Sex: Female, Male Female | 24 Participants | 39 Participants | 15 Participants |
| Sex: Female, Male Male | 31 Participants | 58 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 55 | 2 / 42 |
| serious Total, serious adverse events | 0 / 55 | 0 / 42 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Return to Function | 1257.45 units on a scale | Standard Deviation 396.07 |
| Double Row With PRFM | Return to Function | 1106.31 units on a scale | Standard Deviation 393.78 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Return to Function | 371.38 units on a scale | Standard Deviation 312.18 |
| Double Row With PRFM | Return to Function | 297.13 units on a scale | Standard Deviation 221.21 |
Primary
Return to Function
Western Ontario Rotator Cuff Index
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Return to Function | 174.8 units on a scale | Standard Deviation 254.41 |
| Double Row With PRFM | Return to Function | 103.11 units on a scale | Standard Deviation 144.03 |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Infraspinatus Strength Measurements | 102.0 percentage of uninvolved | Standard Deviation 23 |
| Double Row With PRFM | Infraspinatus Strength Measurements | 104.0 percentage of uninvolved | Standard Deviation 13 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Infraspinatus Strength Measurements | 73.6 percentage of uninvolved | Standard Deviation 67.4 |
| Double Row With PRFM | Infraspinatus Strength Measurements | 73.7 percentage of uninvolved | Standard Deviation 24.3 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Infraspinatus Strength Measurements | 90.0 percentage of uninvolved | Standard Deviation 33 |
| Double Row With PRFM | Infraspinatus Strength Measurements | 96.0 percentage of uninvolved | Standard Deviation 22 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | MRI | 3.21 scores on a scale | Standard Deviation 1.07 |
| Double Row With PRFM | MRI | 2.74 scores on a scale | Standard Deviation 1.02 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Spraspinatus Strength Measurements | 45.4 percentage of uninvolved | Standard Deviation 34.2 |
| Double Row With PRFM | Spraspinatus Strength Measurements | 51.8 percentage of uninvolved | Standard Deviation 32.3 |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Supraspinatus Strength Measurements | 101.0 percentage of uninvolved | Standard Deviation 53 |
| Double Row With PRFM | Supraspinatus Strength Measurements | 96.0 percentage of uninvolved | Standard Deviation 17 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Row | Supraspinatus Strength Measurements | 73.0 percentage of uninvolved | Standard Deviation 29 |
| Double Row With PRFM | Supraspinatus Strength Measurements | 81.0 percentage of uninvolved | Standard Deviation 26 |