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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received the Quattro X BroadBand | No specific interventions will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From operation to study completion, 0-1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair, according to the IFU and who meet all of the inclusion and none of exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ortheo | Saint-Etienne | 42100 | France | |||
| Centre Clinical |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Who Received the Quattro X BroadBand | No specific interventions will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Who Received the Quattro X BroadBand | No specific interventions will be administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age is recorded at the time of the surgery |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | From operation to study completion, 0-1 year |
|
From surgery to last assessment 1 year postoperatively
Adverse Events were collected retrospectively from the patients medical notes and prospectively at the 1 year follow up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Who Received the Quattro X BroadBand | No specific interventions will be administered. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complex Regional Pain Syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Nicoux | Zimmer Biomet | +33672613502 | julie.nicoux@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2022 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| From operation to study completion, 0-1 year |
| 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). | From operation to study completion, 0-1 year |
| Assessment of Safety | Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events | From operation to study completion, 0-1 year |
| Subjective Shoulder Value | The Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. | From operation to study completion, 0-1 year |
| Pain / Anti-Inflammatory Medication | Does The Patient Take Pain/Anti-Inflammatory Medication? | 1 year after surgery |
| Patient Satisfaction | Patient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed. | 1 year after surgery |
| 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. | 1 year after surgery |
| Soyaux |
| 16800 |
| France |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Symptom Duration | Mean | Standard Deviation | days |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Operated Side | Count of Participants | Participants |
|
| Patient Employment Before Surgery | Count of Participants | Participants |
|
| Dominant Shoulder | Count of Participants | Participants |
|
| Current Tobacco Use | Count of Participants | Participants |
|
| Current Alcohol Use | Count of Participants | Participants |
|
| Constant and Murley | 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). | not all patients had baseline data available | Mean | Standard Deviation | units on a scale |
|
| EQ5D | The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 (best outcome) and the lowest score is -0.573 (worst outcome). | not all patients had baseline data available | Mean | Standard Deviation | units on a scale |
|
| Subjective Shoulder Value | The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal. | not all patients had baseline data available | Mean | Standard Deviation | Percentage |
|
| Prior Ipsilateral Shoulder Infection | Count of Participants | Participants |
|
| Prior Contralateral Shoulder Infection | Count of Participants | Participants |
|
| Prior Shoulder Operation(s) | Count of Participants | Participants |
|
| Is Contralateral Shoulder in This Study | Count of Participants | Participants |
|
| Functional Demand of Operated Shoulder | Count of Participants | Participants |
|
| Concomitant Diseases | Count of Participants | Participants |
|
| Does The Patient Take Pain/Anti-Inflammatory Medication? | Not all enrolled patients had preoperative data available | Count of Participants | Participants |
|
| Patient Injury | Count of Participants | Participants |
|
| Rotator Cuff Defect | Count of Participants | Participants |
|
| Tendons Involved (e.g., torn) Supra; Infra | Count of Participants | Participants |
|
| Procedure Performed | Count of Participants | Participants |
|
| Units | Counts |
|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | From operation to study completion, 0-1 year |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | From operation to study completion, 0-1 year |
|
|
|
|
| Secondary | Assessment of Safety | Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events | Posted | Count of Participants | Participants | From operation to study completion, 0-1 year |
|
|
|
| Secondary | Subjective Shoulder Value | The Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. | Posted | Mean | Standard Deviation | Percentage | From operation to study completion, 0-1 year |
|
|
|
|
| Secondary | Pain / Anti-Inflammatory Medication | Does The Patient Take Pain/Anti-Inflammatory Medication? | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed. | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| 9 |
| 106 |
| Re-Tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain and Loss of Strength | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| No |
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| No |
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| No |
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| NSAIDs |
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