Rotator Cuff Tear
Conditions
Keywords
full thickness rotator cuff tear
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.
Detailed 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?
Interventions
PROCEDUREsingle row
This method involves using a single row of anchor(s) to reattach the cuff to the bone.
PROCEDUREdouble 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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Score | 2 Year | 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. |
| ASES Score | 2 Year | 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. |
| Strength Test | 2 Years | Shoulder strength in forward elevation was measured in kg using a portable scale. |
| Healing Rate | 1 Year | 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). |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
Nine patients were never randomized because they either postponed or canceled the surgery, and nineteen patients were excluded prior to randomization for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Single Row Fixation single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone. | 48 |
| 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. | 42 |
| Total | 90 |
Baseline characteristics
| Characteristic | Single Row Fixation | Double Row Fixation | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 8.9 | 57.8 years STANDARD_DEVIATION 7 | 56.8 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Canada | 48 participants | 42 participants | 90 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 35 Participants | 29 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 42 |
| serious Total, serious adverse events | 0 / 48 | 0 / 42 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Row Fixation | Western Ontario Rotator Cuff Index (WORC) | 84.4 units on a scale | Standard Deviation 21.3 |
| Double Row Fixation | Western Ontario Rotator Cuff Index (WORC) | 81.7 units on a scale | Standard Deviation 20.9 |
p-value: 0.6t-test, 2 sided
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.
Time frame: 2 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Row Fixation | ASES Score | 87.9 units on a scale | Standard Deviation 16.9 |
| Double Row Fixation | ASES Score | 89.3 units on a scale | Standard Deviation 17.5 |
p-value: 0.05t-test, 2 sided
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.
Time frame: 2 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Row Fixation | Constant Score | 85.6 units on a scale | Standard Deviation 14 |
| Double Row Fixation | Constant Score | 86.3 units on a scale | Standard Deviation 14.2 |
p-value: 0.05t-test, 2 sided
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).
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Row Fixation | Healing Rate | 67 percentage of patients |
| Double Row Fixation | Healing Rate | 78 percentage of patients |
p-value: 0.05Chi-squared
Secondary
Strength Test
Shoulder strength in forward elevation was measured in kg using a portable scale.
Time frame: 2 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Row Fixation | Strength Test | 8.0 kg | Standard Deviation 6 |
| Double Row Fixation | Strength Test | 7.3 kg | Standard Deviation 3.2 |