Rotator Cuff Injury
Conditions
Keywords
Rotator cuff, Ossification, Suture anchors
Brief summary
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
Interventions
DEVICESuture Anchor HEALOCOIL
Rotator cuff tears will be repaired intraoperatively using suture anchors
DEVICESuture anchor Twinfix Ultra HA
Sponsors
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 35 to 75 years at the time of surgery. * Willing and able to give voluntary informed consent to participate in this investigation. * Full thickness tear of the rotator cuff * Tear requires repair within one year of initial diagnosis. * Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity). * Willing and able, in the opinion of the Investigator, to cooperate with study procedures, and willing to return to study site for all required post-operative study visits.
Exclusion criteria
* Evidence of acute trauma including fracture or dislocation of the shoulder joint. * Chronic retraction. * Evidence of active infection, osteomyelitis, sepsis or distant infection, which could spread to the index joint. * Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder. * Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date. * Evidence of osteomalacia or other metabolic bone disorder(s), which may impair bone or soft tissue function. * Evidence of other significant shoulder pathology including (Type II-IV lesion, Bankart lesion, Hill Sachs lesion). * Patient has grade 4 changes to articular cartilage in operative shoulder * Inflammatory arthropathies. * Significant muscle paralysis of the shoulder girdle. * Painful pathologies of the cervical spine. * Comminuted bone surface, which would compromise secure anchor fixation. * Non-surgical rotator cuff associated treatment, such as corticosteroid injection, within one (1) month prior to scheduled surgery date. * Participating in another investigational trial or ongoing study that would interfere with the assessment of the primary and secondary outcomes. * Female patient who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. * Major psychiatric illness, developmental handicap or inability to read and understand the English language. * Major medical illness that would preclude undergoing surgery. * Known to be involved in any active injury litigation claims relating to the study shoulder. * Unwilling or unable to be assessed according to study protocol for two years following surgery. * Patient requires a concomitant SLAP repair procedure in operative shoulder. * Surgeon plans to use a Platelet Rich Plasma product or another therapy intended to augment healing of the rotator cuff in the study procedure. * Protocol specified surgical technique cannot be followed for this subject. * Rotator cuff repair will be done via open (as opposed to arthroscopic) procedure. * Any other reason (in the judgment of the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ossification Quality Score (Bony Ingrowth Assessed Via CT) | 2 years | The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects little or no bone ossification, Quality score 2 reflects Some ossification; discontinuous or with a wide lucent rim, Quality score 3 reflects Ossification with a thin lucent rim, and Quality score 4 reflects Good ossification; border of tract vague. For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification). The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Rotator Cuff Re-tear | 6 months | Repair failure rate (Defined as number of subjects with a re-tear) determined by ultrasound 6 months after surgery. |
| Visual Analogue Pain Scale | 2 years | The Visual Analogue Pain Scale (VAS) measures the patient-reported level of pain at the two-year follow-up. The scale runs from 0 to 10, with 0 indicating no pain and 10 indicating extreme pain. The lower the VAS Pain level, the better the outcome in regards to level of pain. |
| Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | 2 years | Outcomes at Two Years on the following: * Western Ontario Rotator Cuff Index (WORC): developed to help understand the particular signs, symptoms, and functional limitations associated with rotator cuff tendinopathy. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * PENN Shoulder Score (PENN): The PENN is a 100-point shoulder-specific self-report questionnaire evaluating pain, satisfaction, and shoulder function. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * Single Assessment Numeric Evaluation (SANE): A single question that asks How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)? 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. * Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating The best health you can imagine and |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEALICOIL Regenesorb Suture anchor for rotator cuff repair
Suture Anchor HEALOCOIL: Rotator cuff tears will be repaired intraoperatively using suture anchors | 32 |
| Twinfix Ultra HA Suture anchor for rotator cuff repair
Suture anchor Twinfix Ultra HA | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Twinfix Ultra HA | Total | HEALICOIL Regenesorb |
|---|---|---|---|
| Age, Continuous | 57 years | 59 years | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 64 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 54 Participants | 26 Participants |
| Region of Enrollment United States | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 19 Participants | 39 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Ossification Quality Score (Bony Ingrowth Assessed Via CT)
The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects little or no bone ossification, Quality score 2 reflects Some ossification; discontinuous or with a wide lucent rim, Quality score 3 reflects Ossification with a thin lucent rim, and Quality score 4 reflects Good ossification; border of tract vague. For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification). The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification.
Time frame: 2 years
Population: The Ossification Quality Score will be assessed for each anchor implanted into a study subjects' shoulder. Because many subjects have more than one rotator cuff suture anchor implanted, the overall number of units analyzed will be greater than the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| HEALICOIL Regenesorb | Ossification Quality Score (Bony Ingrowth Assessed Via CT) | Number of High Quality Ossification Anchors | 42 Suture Anchors |
| HEALICOIL Regenesorb | Ossification Quality Score (Bony Ingrowth Assessed Via CT) | Number of Low Quality Ossification Anchors | 15 Suture Anchors |
| Twinfix Ultra HA | Ossification Quality Score (Bony Ingrowth Assessed Via CT) | Number of High Quality Ossification Anchors | 36 Suture Anchors |
| Twinfix Ultra HA | Ossification Quality Score (Bony Ingrowth Assessed Via CT) | Number of Low Quality Ossification Anchors | 24 Suture Anchors |
Secondary
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D)
Outcomes at Two Years on the following: * Western Ontario Rotator Cuff Index (WORC): developed to help understand the particular signs, symptoms, and functional limitations associated with rotator cuff tendinopathy. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * PENN Shoulder Score (PENN): The PENN is a 100-point shoulder-specific self-report questionnaire evaluating pain, satisfaction, and shoulder function. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst. * Single Assessment Numeric Evaluation (SANE): A single question that asks How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)? 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. * Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating The best health you can imagine and
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEALICOIL Regenesorb | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | SANE | 84.2 score on a scale | Standard Deviation 20.9 |
| HEALICOIL Regenesorb | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | WORC | 78.7 score on a scale | Standard Deviation 25.2 |
| HEALICOIL Regenesorb | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | PENN | 88.0 score on a scale | Standard Deviation 13.6 |
| HEALICOIL Regenesorb | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | EQ-5D | 83.3 score on a scale | Standard Deviation 16.3 |
| Twinfix Ultra HA | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | EQ-5D | 87.3 score on a scale | Standard Deviation 7.4 |
| Twinfix Ultra HA | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | SANE | 86.7 score on a scale | Standard Deviation 13.9 |
| Twinfix Ultra HA | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | PENN | 88.6 score on a scale | Standard Deviation 10.4 |
| Twinfix Ultra HA | Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D) | WORC | 84.6 score on a scale | Standard Deviation 13.5 |
Secondary
Number of Participants With a Rotator Cuff Re-tear
Repair failure rate (Defined as number of subjects with a re-tear) determined by ultrasound 6 months after surgery.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEALICOIL Regenesorb | Number of Participants With a Rotator Cuff Re-tear | 6 Participants |
| Twinfix Ultra HA | Number of Participants With a Rotator Cuff Re-tear | 2 Participants |
Secondary
Visual Analogue Pain Scale
The Visual Analogue Pain Scale (VAS) measures the patient-reported level of pain at the two-year follow-up. The scale runs from 0 to 10, with 0 indicating no pain and 10 indicating extreme pain. The lower the VAS Pain level, the better the outcome in regards to level of pain.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEALICOIL Regenesorb | Visual Analogue Pain Scale | 1.2 score on a scale | Standard Deviation 1.3 |
| Twinfix Ultra HA | Visual Analogue Pain Scale | 1.8 score on a scale | Standard Deviation 1.9 |