Rotator Cuff Injuries, Rotator Cuff Tears
Conditions
Keywords
Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
Brief summary
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair. The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant & Murley and EQ-5D-5L) at 1 year post-operative. The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.
Detailed description
The Quattro® X Suture Anchor with BroadBand™ Tape is intended for use in rotator cuff repairs. It is intended for for the reattachment of soft tissue to bone. Up to three sites will be involved in this study. The aim is to include a total of 109 consecutive series cases who received the Quattro® X Suture Anchor with BroadBand™ Tape. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair; 2. Older than 18 years and skeletally mature; 3. Willing and able to comply with the study procedures; 4. Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program; 5. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.
Exclusion criteria
1. Presence of infection; 2. Insufficient or immature bone; 3. Insufficient blood supply or previous infections which may hinder the healing process; 4. Foreign body sensitivity; 5. Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant); 6. The subject is unwilling or unable to give consent or to comply with the follow-up program; 7. Subject meets any contraindications of the appropriate Instruction for Use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) | From operation to study completion, 0-1 year | The investigator will clinically evaluate at 1 year follow-up visit if soft tissue to bone healing has occurred by the absence of device-related revisions and re-tears that were not previously reported. The following question will be asked to the investigator: Did soft tissue to bone healing occur? If yes is answered, then the soft tissue to bone healing is successful, if no is answered, then the soft tissue to bone healing is considered unsuccessful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L Score | From operation to study completion, 0-1 year | Assessment of clinical benefits by functional outcomes measured using standard scoring systems. The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS. Each dimension is assigned one of three discrete levels for evaluation on the day of administration: Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between. In the derived EQ-5D-5L score, the highest score is 1 (best outcome) and the lowest score is -0.573 (worst outcome). |
| Assessment of Safety | From operation to study completion, 0-1 year | Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events |
| Subjective Shoulder Value | From operation to study completion, 0-1 year | The Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. |
| Constant and Murley Score | From operation to study completion, 0-1 year | The Constant and Murley 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. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome). |
| Patient Satisfaction | 1 year after surgery | Patient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed. |
| Would The Patient Have This Surgery Again? | 1 year after surgery | 1 year after their surgery, patients were asked if yes or no they would have the surgery again. |
| Pain / Anti-Inflammatory Medication | 1 year after surgery | Does The Patient Take Pain/Anti-Inflammatory Medication? |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Who Received the Quattro X BroadBand No specific interventions will be administered. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Patients Who Received the Quattro X BroadBand | — |
|---|---|---|
| Age, Customized Age at surgery | 61.6 Years STANDARD_DEVIATION 8.6 | — |
| BMI | 26.0 kg/m2 STANDARD_DEVIATION 3.3 | — |
| Concomitant Diseases No | 106 Participants | — |
| Concomitant Diseases Yes | 0 Participants | — |
| Constant and Murley | 49.9 units on a scale STANDARD_DEVIATION 8.4 | — |
| Current Alcohol Use Daily | 1 Participants | — |
| Current Alcohol Use Monthly | 4 Participants | — |
| Current Alcohol Use None | 91 Participants | — |
| Current Alcohol Use Occasionally | 5 Participants | — |
| Current Alcohol Use Weekly | 5 Participants | — |
| Current Tobacco Use Less than one pack per day | 9 Participants | — |
| Current Tobacco Use None | 97 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Narcotic Analgesics Daily | 1 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Narcotic Analgesics Monthly | 0 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Narcotic Analgesics No | 47 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Narcotic Analgesics Weekly | 1 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Non-Narcotic Analgesics Daily | 1 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Non-Narcotic Analgesics Monthly | 2 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Non-Narcotic Analgesics No | 36 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Non-Narcotic Analgesics Weekly | 10 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? NSAIDs Daily | 2 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? NSAIDs Monthly | 4 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? NSAIDs No | 38 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? NSAIDs Weekly | 5 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Steroids Daily | 0 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Steroids Monthly | 0 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Steroids No | 48 Participants | — |
| Does The Patient Take Pain/Anti-Inflammatory Medication? Steroids Weekly | 1 Participants | — |
| Dominant Shoulder Left | 7 Participants | — |
| Dominant Shoulder Right | 99 Participants | — |
| EQ5D | 0.882 units on a scale STANDARD_DEVIATION 0.119 | — |
| Functional Demand of Operated Shoulder High | 51 Participants | — |
| Functional Demand of Operated Shoulder Low | 9 Participants | — |
| Functional Demand of Operated Shoulder Medium | 46 Participants | — |
| Height | 169.9 cm STANDARD_DEVIATION 8.9 | — |
| Is Contralateral Shoulder in This Study No | 105 Participants | — |
| Is Contralateral Shoulder in This Study Yes | 1 Participants | — |
| Operated Side Left | 34 Participants | — |
| Operated Side Right | 72 Participants | — |
| Patient Employment Before Surgery Full Time | 50 Participants | — |
| Patient Employment Before Surgery Not Employed | 3 Participants | — |
| Patient Employment Before Surgery Parti Time | 6 Participants | — |
| Patient Employment Before Surgery Retired | 47 Participants | — |
| Patient Injury Chronic Degeneration of the Rotator Cuff | 81 Participants | — |
| Patient Injury Sustained Injury | 25 Participants | — |
| Prior Contralateral Shoulder Infection No | 106 Participants | — |
| Prior Contralateral Shoulder Infection Yes | 0 Participants | — |
| Prior Ipsilateral Shoulder Infection No | 106 Participants | — |
| Prior Ipsilateral Shoulder Infection Yes | 0 Participants | — |
| Prior Shoulder Operation(s) Contralateral Rotator Cuff Repair | 3 Participants | — |
| Prior Shoulder Operation(s) Ipsilateral Rotator Cuff Repair | 1 Participants | — |
| Prior Shoulder Operation(s) No | 102 Participants | — |
| Procedure Performed Double Row Repair | 105 Participants | — |
| Procedure Performed Single Row Repair | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Rotator Cuff Defect Large (4-5cm) | 29 Participants | — |
| Rotator Cuff Defect Massive (<5cm) | 7 Participants | — |
| Rotator Cuff Defect Medium (1-3 cm) | 63 Participants | — |
| Rotator Cuff Defect Small (< 1 cm) | 7 Participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 66 Participants | — |
| Subjective Shoulder Value | 63.3 Percentage STANDARD_DEVIATION 9.1 | — |
| Symptom Duration | 349.7 days STANDARD_DEVIATION 372.8 | — |
| Tendons Involved (e.g., torn) Supra; Infra Subscap | 1 Participants | — |
| Tendons Involved (e.g., torn) Supra; Infra Supra | 8 Participants | — |
| Tendons Involved (e.g., torn) Supra; Infra Supra, Infra | 57 Participants | — |
| Tendons Involved (e.g., torn) Supra; Infra Supra, Infra, Subscap | 7 Participants | — |
| Tendons Involved (e.g., torn) Supra; Infra Supra, Subscap | 33 Participants | — |
| Weight | 75.2 kg STANDARD_DEVIATION 11.7 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 9 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff)
The investigator will clinically evaluate at 1 year follow-up visit if soft tissue to bone healing has occurred by the absence of device-related revisions and re-tears that were not previously reported. The following question will be asked to the investigator: Did soft tissue to bone healing occur? If yes is answered, then the soft tissue to bone healing is successful, if no is answered, then the soft tissue to bone healing is considered unsuccessful.
Time frame: From operation to study completion, 0-1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) | Yes | 105 Participants |
| Patients Who Received the Quattro X BroadBand | Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) | No | 1 Participants |
Secondary
Assessment of Safety
Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events
Time frame: From operation to study completion, 0-1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Assessment of Safety | Patients with adverse events | 9 Participants |
| Patients Who Received the Quattro X BroadBand | Assessment of Safety | Patients without adverse events | 97 Participants |
Secondary
Constant and Murley Score
The Constant and Murley 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. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).
Time frame: From operation to study completion, 0-1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Constant and Murley Score | 67.9 units on a scale | Standard Deviation 14.7 |
p-value: <0.000195% CI: [9.2, 15]paired t-test
Secondary
EQ-5D-5L Score
Assessment of clinical benefits by functional outcomes measured using standard scoring systems. The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS. Each dimension is assigned one of three discrete levels for evaluation on the day of administration: Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between. In the derived EQ-5D-5L score, the highest score is 1 (best outcome) and the lowest score is -0.573 (worst outcome).
Time frame: From operation to study completion, 0-1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | EQ-5D-5L Score | 0.95 units on a scale | Standard Deviation 0.104 |
p-value: <0.000195% CI: [0.053, 0.128]paired t-test
Secondary
Pain / Anti-Inflammatory Medication
Does The Patient Take Pain/Anti-Inflammatory Medication?
Time frame: 1 year after surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | NSAIDs | Daily | 0 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | Non-Narcotic Analgesics | Daily | 1 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | Non-Narcotic Analgesics | Weekly | 6 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | Non-Narcotic Analgesics | Monthly | 1 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | Non-Narcotic Analgesics | None | 98 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | NSAIDs | Weekly | 4 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | NSAIDs | Monthly | 0 Participants |
| Patients Who Received the Quattro X BroadBand | Pain / Anti-Inflammatory Medication | NSAIDs | None | 102 Participants |
Secondary
Patient Satisfaction
Patient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed.
Time frame: 1 year after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Patient Satisfaction | Very Satisfied | 76 Participants |
| Patients Who Received the Quattro X BroadBand | Patient Satisfaction | Satisfied | 21 Participants |
| Patients Who Received the Quattro X BroadBand | Patient Satisfaction | Somewhat Satisfied | 7 Participants |
| Patients Who Received the Quattro X BroadBand | Patient Satisfaction | Disappointed | 2 Participants |
Secondary
Subjective Shoulder Value
The Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder.
Time frame: From operation to study completion, 0-1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Subjective Shoulder Value | 86.1 Percentage | Standard Deviation 13.3 |
p-value: <0.000195% CI: [16.9, 24.5]paired t-test
Secondary
Would The Patient Have This Surgery Again?
1 year after their surgery, patients were asked if yes or no they would have the surgery again.
Time frame: 1 year after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Quattro X BroadBand | Would The Patient Have This Surgery Again? | Yes | 85 Participants |
| Patients Who Received the Quattro X BroadBand | Would The Patient Have This Surgery Again? | No | 21 Participants |