Rotator Cuff Tear
Conditions
Keywords
Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
Brief summary
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
Detailed description
Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.
Interventions
DEVICEConexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Sponsors
LifeCell
Stryker Trauma and Extremities
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
The patient: 1. is an adult male or female between the ages of 40-70 years old; 2. has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm; 3. requires surgical repair of single rotator cuff (i.e. one limb); 4. has movement of the non-operative arm defined as shoulder elevation of equal to or greater than 90 degrees and is able to perform postoperative exercises; 5. is able to return for all scheduled and required study visits; 6. is able to provide written informed consent for study participation.
Exclusion criteria
The patient: 1. has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension; 2. has a rotator cuff tear \< 3cm (measured intra-operatively); 3. has a rotator cuff tear \> 5cm (measured intra-operatively); 4. has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair; 5. has grade 3 or 4 fatty infiltration of the rotator cuff; 6. has had prior surgical repair to the affected shoulder; 7. is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I); 8. is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study. 9. has lower limb injuries requiring walking assist devices such as crutches and walkers; 10. has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome. 11. has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon; 12. has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection; 13. has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction; 14. is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial; 15. has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate. 16. has an inability to have a closed MRI conducted. 17. needs a re-operation for a re-tear of the rotator cuff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Score (ASES) | baseline, post-op months 3, 6, 12, and 24 | The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst. |
| Adjusted Constant-Murley Score | baseline, post-op months 6, 12, and 24 | The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005). |
| Simple Shoulder Test (SST) | baseline, post-op months 3, 6, 12, and 24 | The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rotator Cuff Re-tear Evaluation | Post-op months 6 and 12 | Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported. Two different definitions of a re-tear were used for the analysis. 1. Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size. 2. Sub-analysis: Full thickness tear one centimeter or greater in length. |
| Isometric Strength | baseline, post-op months 6, 12, and 24 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complications, Including Infection | All time points | Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conexa Rotator cuff repair using Conexa | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Conexa |
|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 6.5 |
| BMI | 32 kg/m^2 STANDARD_DEVIATION 6.8 |
| Height | 171.5 cm STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized Black or African American | 5 participants |
| Race/Ethnicity, Customized White | 56 participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 38 Participants |
| Weight | 94.9 kg STANDARD_DEVIATION 24.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 61 |
| serious Total, serious adverse events | 1 / 61 |
Outcome results
Primary
Adjusted Constant-Murley Score
The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).
Time frame: baseline, post-op months 6, 12, and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conexa | Adjusted Constant-Murley Score | Baseline Measurement | 45.4 units on a scale | Standard Deviation 15.2 |
| Conexa | Adjusted Constant-Murley Score | 6 Month Measurement | 62.9 units on a scale | Standard Deviation 11.6 |
| Conexa | Adjusted Constant-Murley Score | 12 Month Measurement | 68.7 units on a scale | Standard Deviation 11.3 |
| Conexa | Adjusted Constant-Murley Score | 24 Month Measurement | 71.7 units on a scale | Standard Deviation 9.6 |
Primary
American Shoulder and Elbow Score (ASES)
The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.
Time frame: baseline, post-op months 3, 6, 12, and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conexa | American Shoulder and Elbow Score (ASES) | Baseline Measurement | 48.7 units on a scale | Standard Deviation 20.2 |
| Conexa | American Shoulder and Elbow Score (ASES) | 3 Month Measurement | 69.4 units on a scale | Standard Deviation 16.2 |
| Conexa | American Shoulder and Elbow Score (ASES) | 6 Month Measurement | 79.9 units on a scale | Standard Deviation 17.7 |
| Conexa | American Shoulder and Elbow Score (ASES) | 12 Month Measurement | 85.4 units on a scale | Standard Deviation 18.4 |
| Conexa | American Shoulder and Elbow Score (ASES) | 24 Month Measurement | 90.4 units on a scale | Standard Deviation 15.3 |
Primary
Simple Shoulder Test (SST)
The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.
Time frame: baseline, post-op months 3, 6, 12, and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conexa | Simple Shoulder Test (SST) | Baseline Measurement | 5.0 units on a scale | Standard Deviation 2.6 |
| Conexa | Simple Shoulder Test (SST) | 3 Month Measurement | 6.4 units on a scale | Standard Deviation 3 |
| Conexa | Simple Shoulder Test (SST) | 6 Month Measurement | 8.7 units on a scale | Standard Deviation 2.7 |
| Conexa | Simple Shoulder Test (SST) | 12 Month Measurement | 9.9 units on a scale | Standard Deviation 2.5 |
| Conexa | Simple Shoulder Test (SST) | 24 Month Measurement | 10.6 units on a scale | Standard Deviation 2.2 |
Secondary
Isometric Strength
Time frame: baseline, post-op months 6, 12, and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conexa | Isometric Strength | Baseline Measurement | 34.4 newtons (N) | Standard Deviation 26.8 |
| Conexa | Isometric Strength | 6 Month Measurement | 61.9 newtons (N) | Standard Deviation 52.8 |
| Conexa | Isometric Strength | 12 Month Measurement | 83.0 newtons (N) | Standard Deviation 71.7 |
| Conexa | Isometric Strength | 24 Month Measurement | 78.6 newtons (N) | Standard Deviation 63.2 |
Secondary
Rotator Cuff Re-tear Evaluation
Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported. Two different definitions of a re-tear were used for the analysis. 1. Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size. 2. Sub-analysis: Full thickness tear one centimeter or greater in length.
Time frame: Post-op months 6 and 12
Population: Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conexa | Rotator Cuff Re-tear Evaluation | 80% re-tear Definition, 6 months | 18.5 percentage of participants |
| Conexa | Rotator Cuff Re-tear Evaluation | 80% re-tear definition, 12 months | 16.9 percentage of participants |
| Conexa | Rotator Cuff Re-tear Evaluation | 1 cm re-tear definition, 6 months | 32.2 percentage of participants |
| Conexa | Rotator Cuff Re-tear Evaluation | 1 cm re-tear definition, 12 months | 33.9 percentage of participants |
Other Pre-specified
Incidence of Complications, Including Infection
Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.
Time frame: All time points
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conexa | Incidence of Complications, Including Infection | Inflammation (surgical site, wound);Severity: Mild | 9.8 percentage of participants |
| Conexa | Incidence of Complications, Including Infection | Re-tear;Severity: Mild | 9.8 percentage of participants |