Rotator Cuff Failure With Continuity
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/19/2018 |
| Start Date: | September 2016 |
| End Date: | April 2021 |
| Contact: | Cathy Shemo |
| Email: | shemoc@ccf.org |
| Phone: | 2164445971 |
Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes
This proposal's objective is to challenge and expand the current definition of rotator cuff
healing by investigating tendon retraction - broadly defined as medial translation of the
repaired tendon away from the bone with or without a defect - as a common and clinically
predictive structural outcome following rotator cuff repair. The investigators' central
hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon
of rotator cuff healing that is significantly and meaningfully correlated with clinical
outcomes. The investigators' approach is to characterize tendon retraction using an array of
implanted radio-opaque markers, and investigate its relationship to pre-operative tissue
quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a
125-patient prospective cohort study. These patients will complete (1) validated
questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery,
3 weeks, and 3, 6, 12 and 24 months post-operatively, (3) MRI at 3 weeks and 3, 6, 12 and 24
months post-operatively and (4) questionnaires, range of motion and strength testing at 3, 6,
12 and 24 months post-operatively.
healing by investigating tendon retraction - broadly defined as medial translation of the
repaired tendon away from the bone with or without a defect - as a common and clinically
predictive structural outcome following rotator cuff repair. The investigators' central
hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon
of rotator cuff healing that is significantly and meaningfully correlated with clinical
outcomes. The investigators' approach is to characterize tendon retraction using an array of
implanted radio-opaque markers, and investigate its relationship to pre-operative tissue
quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a
125-patient prospective cohort study. These patients will complete (1) validated
questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery,
3 weeks, and 3, 6, 12 and 24 months post-operatively, (3) MRI at 3 weeks and 3, 6, 12 and 24
months post-operatively and (4) questionnaires, range of motion and strength testing at 3, 6,
12 and 24 months post-operatively.
Currently, rotator cuff healing is defined as "intact", "attenuated", or "failed" based on
the observation (or not) of a recurrent defect (i.e., a "gap") in the tendon using MRI or
ultrasound imaging. The investigators' previous work has identified a new outcome, in which
there is no detectable defect or "gap" in the repaired tendon, but the repaired tendon has
undergone significant retraction. The investigators call this outcome "failure with
continuity".
Current imaging methods are inadequate to determine the extent to which the repaired rotator
cuff tendon has "failed with continuity". The investigators have developed an imaging
technique to detect this phenomenon. Specifically, radio-opaque markers are sutured onto the
repaired tendon and impacted into the nearby arm bone. The distance between the tendon and
bone markers is measured from CT scans taken within 2 weeks of surgery, and compared to the
distance between the markers at 3, 6, 12 and 24 months. If the tendon retracts away from the
bone during healing, the distance between the tendon and bone markers will increase over
time. Healing of the tendon will also be monitored in the traditional manner by MRI scans at
the same time points. The investigators will investigate the relationship between tendon
retraction, MR imaging and clinical outcomes including shoulder strength and patient
satisfaction.
The investigators expect to show that tendon retraction is common, occurs early
post-operatively, with or without repair continuity as assessed by traditional imaging, and
significantly correlates with clinical outcomes. The immediate and highly significant
consequence of this finding would be a paradigm shift in the investigators' understanding of
tendon repair healing, now incorporating the magnitude, timing and location of tendon
retraction as well as the continuity of the repaired tissue. This information would yield a
more precise understanding of rotator cuff tendon healing, allowing for advances in treatment
strategies that improve surgical healing and clinical outcomes and result in more durable
rotator cuff repairs over time.
the observation (or not) of a recurrent defect (i.e., a "gap") in the tendon using MRI or
ultrasound imaging. The investigators' previous work has identified a new outcome, in which
there is no detectable defect or "gap" in the repaired tendon, but the repaired tendon has
undergone significant retraction. The investigators call this outcome "failure with
continuity".
Current imaging methods are inadequate to determine the extent to which the repaired rotator
cuff tendon has "failed with continuity". The investigators have developed an imaging
technique to detect this phenomenon. Specifically, radio-opaque markers are sutured onto the
repaired tendon and impacted into the nearby arm bone. The distance between the tendon and
bone markers is measured from CT scans taken within 2 weeks of surgery, and compared to the
distance between the markers at 3, 6, 12 and 24 months. If the tendon retracts away from the
bone during healing, the distance between the tendon and bone markers will increase over
time. Healing of the tendon will also be monitored in the traditional manner by MRI scans at
the same time points. The investigators will investigate the relationship between tendon
retraction, MR imaging and clinical outcomes including shoulder strength and patient
satisfaction.
The investigators expect to show that tendon retraction is common, occurs early
post-operatively, with or without repair continuity as assessed by traditional imaging, and
significantly correlates with clinical outcomes. The immediate and highly significant
consequence of this finding would be a paradigm shift in the investigators' understanding of
tendon repair healing, now incorporating the magnitude, timing and location of tendon
retraction as well as the continuity of the repaired tissue. This information would yield a
more precise understanding of rotator cuff tendon healing, allowing for advances in treatment
strategies that improve surgical healing and clinical outcomes and result in more durable
rotator cuff repairs over time.
Inclusion Criteria:
- Males or females, ages 18-75 having an acute or chronic 1-5 cm wide (A-P) full
thickness tear of only the supraspinatus and/or infraspinatus tendons; partial
thickness tears of subscapularis or teres minor not requiring repair are allowed.
- The tear must be fully reparable arthroscopically by a double row technique.
- Final determination of eligibility will be made at surgery when above inclusion
criteria are confirmed.
Exclusion Criteria:
- Prior shoulder surgery (including rotator cuff repair)
- Symptomatic cervical spine disease
- A frozen shoulder-- defined as a loss of passive range of motion (ROM) of more than
20° in any plane compared to the contralateral shoulder,
- Glenohumeral arthritis-- defined as full thickness cartilage loss on MRI and confirmed
at arthroscopy
- Worker's compensation cases
- Isolated subscapularis tears > 1cm
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