Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband (NCT NCT05690776)
NCT ID: NCT05690776
Last Updated: 2025-09-10
Results Overview
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.
COMPLETED
106 participants
From operation to study completion, 0-1 year
2025-09-10
Participant Flow
Participant milestones
| Measure |
Patients Who Received the Quattro X BroadBand
No specific interventions will be administered.
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Age, Customized
Age at surgery
|
61.6 Years
STANDARD_DEVIATION 8.6 • n=106 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=106 Participants
|
|
BMI
|
26.0 kg/m2
STANDARD_DEVIATION 3.3 • n=106 Participants
|
|
Symptom Duration
|
349.7 days
STANDARD_DEVIATION 372.8 • n=106 Participants
|
|
Weight
|
75.2 kg
STANDARD_DEVIATION 11.7 • n=106 Participants
|
|
Height
|
169.9 cm
STANDARD_DEVIATION 8.9 • n=106 Participants
|
|
Operated Side
Left
|
34 Participants
n=106 Participants
|
|
Operated Side
Right
|
72 Participants
n=106 Participants
|
|
Patient Employment Before Surgery
Full Time
|
50 Participants
n=106 Participants
|
|
Patient Employment Before Surgery
Parti Time
|
6 Participants
n=106 Participants
|
|
Patient Employment Before Surgery
Retired
|
47 Participants
n=106 Participants
|
|
Patient Employment Before Surgery
Not Employed
|
3 Participants
n=106 Participants
|
|
Dominant Shoulder
Left
|
7 Participants
n=106 Participants
|
|
Dominant Shoulder
Right
|
99 Participants
n=106 Participants
|
|
Current Tobacco Use
None
|
97 Participants
n=106 Participants
|
|
Current Tobacco Use
Less than one pack per day
|
9 Participants
n=106 Participants
|
|
Current Alcohol Use
None
|
91 Participants
n=106 Participants
|
|
Current Alcohol Use
Daily
|
1 Participants
n=106 Participants
|
|
Current Alcohol Use
Weekly
|
5 Participants
n=106 Participants
|
|
Current Alcohol Use
Monthly
|
4 Participants
n=106 Participants
|
|
Current Alcohol Use
Occasionally
|
5 Participants
n=106 Participants
|
|
Constant and Murley
|
49.9 units on a scale
STANDARD_DEVIATION 8.4 • n=50 Participants • not all patients had baseline data available
|
|
EQ5D
|
0.882 units on a scale
STANDARD_DEVIATION 0.119 • n=50 Participants • not all patients had baseline data available
|
|
Subjective Shoulder Value
|
63.3 Percentage
STANDARD_DEVIATION 9.1 • n=49 Participants • not all patients had baseline data available
|
|
Prior Ipsilateral Shoulder Infection
Yes
|
0 Participants
n=106 Participants
|
|
Prior Ipsilateral Shoulder Infection
No
|
106 Participants
n=106 Participants
|
|
Prior Contralateral Shoulder Infection
Yes
|
0 Participants
n=106 Participants
|
|
Prior Contralateral Shoulder Infection
No
|
106 Participants
n=106 Participants
|
|
Prior Shoulder Operation(s)
Contralateral Rotator Cuff Repair
|
3 Participants
n=106 Participants
|
|
Prior Shoulder Operation(s)
Ipsilateral Rotator Cuff Repair
|
1 Participants
n=106 Participants
|
|
Prior Shoulder Operation(s)
No
|
102 Participants
n=106 Participants
|
|
Is Contralateral Shoulder in This Study
Yes
|
1 Participants
n=106 Participants
|
|
Is Contralateral Shoulder in This Study
No
|
105 Participants
n=106 Participants
|
|
Functional Demand of Operated Shoulder
Low
|
9 Participants
n=106 Participants
|
|
Functional Demand of Operated Shoulder
Medium
|
46 Participants
n=106 Participants
|
|
Functional Demand of Operated Shoulder
High
|
51 Participants
n=106 Participants
|
|
Concomitant Diseases
Yes
|
0 Participants
n=106 Participants
|
|
Concomitant Diseases
No
|
106 Participants
n=106 Participants
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Non-Narcotic Analgesics · Daily
|
1 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Non-Narcotic Analgesics · Weekly
|
10 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Non-Narcotic Analgesics · Monthly
|
2 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Non-Narcotic Analgesics · No
|
36 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Narcotic Analgesics · Daily
|
1 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Narcotic Analgesics · Weekly
|
1 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Narcotic Analgesics · Monthly
|
0 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Narcotic Analgesics · No
|
47 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
NSAIDs · Daily
|
2 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
NSAIDs · Weekly
|
5 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
NSAIDs · Monthly
|
4 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
NSAIDs · No
|
38 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Steroids · Daily
|
0 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Steroids · Weekly
|
1 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Steroids · Monthly
|
0 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Does The Patient Take Pain/Anti-Inflammatory Medication?
Steroids · No
|
48 Participants
n=49 Participants • Not all enrolled patients had preoperative data available
|
|
Patient Injury
Sustained Injury
|
25 Participants
n=106 Participants
|
|
Patient Injury
Chronic Degeneration of the Rotator Cuff
|
81 Participants
n=106 Participants
|
|
Rotator Cuff Defect
Small (< 1 cm)
|
7 Participants
n=106 Participants
|
|
Rotator Cuff Defect
Medium (1-3 cm)
|
63 Participants
n=106 Participants
|
|
Rotator Cuff Defect
Large (4-5cm)
|
29 Participants
n=106 Participants
|
|
Rotator Cuff Defect
Massive (<5cm)
|
7 Participants
n=106 Participants
|
|
Tendons Involved (e.g., torn) Supra; Infra
Supra, Infra
|
57 Participants
n=106 Participants
|
|
Tendons Involved (e.g., torn) Supra; Infra
Supra, Subscap
|
33 Participants
n=106 Participants
|
|
Tendons Involved (e.g., torn) Supra; Infra
Supra
|
8 Participants
n=106 Participants
|
|
Tendons Involved (e.g., torn) Supra; Infra
Supra, Infra, Subscap
|
7 Participants
n=106 Participants
|
|
Tendons Involved (e.g., torn) Supra; Infra
Subscap
|
1 Participants
n=106 Participants
|
|
Procedure Performed
Single Row Repair
|
1 Participants
n=106 Participants
|
|
Procedure Performed
Double Row Repair
|
105 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: From operation to study completion, 0-1 yearThe 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.
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff)
Yes
|
105 Participants
|
|
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff)
No
|
1 Participants
|
SECONDARY outcome
Timeframe: From operation to study completion, 0-1 yearThe 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).
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Constant and Murley Score
|
67.9 units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: From operation to study completion, 0-1 yearAssessment 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).
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
EQ-5D-5L Score
|
0.95 units on a scale
Standard Deviation 0.104
|
SECONDARY outcome
Timeframe: From operation to study completion, 0-1 yearSafety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Assessment of Safety
Patients with adverse events
|
9 Participants
|
|
Assessment of Safety
Patients without adverse events
|
97 Participants
|
SECONDARY outcome
Timeframe: From operation to study completion, 0-1 yearThe Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder.
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Subjective Shoulder Value
|
86.1 Percentage
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: 1 year after surgeryDoes The Patient Take Pain/Anti-Inflammatory Medication?
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Pain / Anti-Inflammatory Medication
Non-Narcotic Analgesics · Daily
|
1 Participants
|
|
Pain / Anti-Inflammatory Medication
Non-Narcotic Analgesics · Weekly
|
6 Participants
|
|
Pain / Anti-Inflammatory Medication
Non-Narcotic Analgesics · Monthly
|
1 Participants
|
|
Pain / Anti-Inflammatory Medication
Non-Narcotic Analgesics · None
|
98 Participants
|
|
Pain / Anti-Inflammatory Medication
NSAIDs · Daily
|
0 Participants
|
|
Pain / Anti-Inflammatory Medication
NSAIDs · Weekly
|
4 Participants
|
|
Pain / Anti-Inflammatory Medication
NSAIDs · Monthly
|
0 Participants
|
|
Pain / Anti-Inflammatory Medication
NSAIDs · None
|
102 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgeryPatient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed.
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Patient Satisfaction
Very Satisfied
|
76 Participants
|
|
Patient Satisfaction
Satisfied
|
21 Participants
|
|
Patient Satisfaction
Somewhat Satisfied
|
7 Participants
|
|
Patient Satisfaction
Disappointed
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgery1 year after their surgery, patients were asked if yes or no they would have the surgery again.
Outcome measures
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 Participants
No specific interventions will be administered.
|
|---|---|
|
Would The Patient Have This Surgery Again?
Yes
|
85 Participants
|
|
Would The Patient Have This Surgery Again?
No
|
21 Participants
|
Adverse Events
Patients Who Received the Quattro X BroadBand
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Who Received the Quattro X BroadBand
n=106 participants at risk
No specific interventions will be administered.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Complex Regional Pain Syndrome
|
6.6%
7/106 • Number of events 7 • 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.
|
|
Musculoskeletal and connective tissue disorders
Re-Tear
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain and Loss of Strength
|
0.94%
1/106 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place