Trial Outcomes & Findings for S&P of Q-Fix™ All-Suture Anchor System (NCT NCT03594071)
NCT ID: NCT03594071
Last Updated: 2021-02-09
Results Overview
All individuals for whom the outcome of re-intervention is known at 6 months
COMPLETED
294 participants
6 months
2021-02-09
Participant Flow
The study enrolled 294 subjects at 5 investigational sites in the United States. This included a total of 309 joints: 134 hips, 118 shoulders, and 57 knees.
Unit of analysis: joints
Participant milestones
| Measure |
Safety Population
All subjects enrolled into the study
|
|---|---|
|
Overall Study
STARTED
|
294 309
|
|
Overall Study
COMPLETED
|
289 304
|
|
Overall Study
NOT COMPLETED
|
5 5
|
Reasons for withdrawal
| Measure |
Safety Population
All subjects enrolled into the study
|
|---|---|
|
Overall Study
Re-operation
|
3
|
|
Overall Study
Missed visit
|
2
|
Baseline Characteristics
Includes all data available for this particular measure (retrospective data)
Baseline characteristics by cohort
| Measure |
Safety Population
n=309 joints
All subjects enrolled into the study
|
|---|---|
|
Age, Continuous
|
37.10 years
STANDARD_DEVIATION 16.60 • n=294 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=294 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
White
|
228 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=294 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
22 Participants
n=294 Participants
|
|
Region of Enrollment
United States
|
294 participants
n=294 Participants
|
|
Height
|
171.19 cm
STANDARD_DEVIATION 11.449 • n=289 Participants • Includes all data available for this particular measure (retrospective data)
|
|
Weight
|
177.33 pounds (lb)
STANDARD_DEVIATION 46.045 • n=288 Participants • Includes all data available for this particular measure (retrospective data)
|
|
Body Mass Index
|
27.39 kg/m^2
STANDARD_DEVIATION 7.060 • n=287 Participants • Includes all data available for this particular measure (retrospective data)
|
|
Ethnicity
Hispanic/Latino
|
15 Participants
n=257 Participants • Includes all data available for this particular measure (retrospective data)
|
|
Ethnicity
Not Hispanic/Latino
|
242 Participants
n=257 Participants • Includes all data available for this particular measure (retrospective data)
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
All individuals for whom the outcome of re-intervention is known at 6 months
Outcome measures
| Measure |
Safety Population
n=309 joints
All subjects enrolled into the study
|
|---|---|
|
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
|
306 joints
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
All individuals for whom the outcome of re-intervention is known at 12 months
Outcome measures
| Measure |
Safety Population
n=122 joints
All subjects enrolled into the study
|
|---|---|
|
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
|
118 joints
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enroll in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System i.e. subjects who only provide retrospective data.
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Outcome measures
| Measure |
Safety Population
n=119 joints
All subjects enrolled into the study
|
|---|---|
|
Hip Visual Analog Scale (VAS) - Pain
Hip: Screening
|
51.0 score on a scale
Standard Deviation 21.7
|
|
Hip Visual Analog Scale (VAS) - Pain
Hip: 6 months
|
24.4 score on a scale
Standard Deviation 20.7
|
|
Hip Visual Analog Scale (VAS) - Pain
Hip: 12 months
|
16.3 score on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Outcome measures
| Measure |
Safety Population
n=8 joints
All subjects enrolled into the study
|
|---|---|
|
Knee Visual Analog Scale (VAS) - Pain
Knee: Screening
|
51.3 score on a scale
Standard Deviation 25.3
|
|
Knee Visual Analog Scale (VAS) - Pain
Knee: 6 months
|
10.0 score on a scale
Standard Deviation 17.3
|
|
Knee Visual Analog Scale (VAS) - Pain
Knee: 12 months
|
23.3 score on a scale
Standard Deviation 40.4
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Outcome measures
| Measure |
Safety Population
n=51 joints
All subjects enrolled into the study
|
|---|---|
|
Shoulder Visual Analog Scale (VAS) - Pain
Shoulder: Screening
|
53.3 score on a scale
Standard Deviation 26.4
|
|
Shoulder Visual Analog Scale (VAS) - Pain
Shoulder: 6 months
|
28.8 score on a scale
Standard Deviation 25.4
|
|
Shoulder Visual Analog Scale (VAS) - Pain
Shoulder: 12 months
|
35.6 score on a scale
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
Full Range of Motion (ROM) defined as full functional arc in hip by the physician.
Outcome measures
| Measure |
Safety Population
n=134 joints
All subjects enrolled into the study
|
|---|---|
|
Hip Range of Motion (ROM)
Hip: Screening - has full functional arc · Yes
|
37 joints
|
|
Hip Range of Motion (ROM)
Hip: Screening - has full functional arc · No
|
90 joints
|
|
Hip Range of Motion (ROM)
Hip: Screening - has full functional arc · Missing
|
7 joints
|
|
Hip Range of Motion (ROM)
Hip: 6 months- has full functional arc · Yes
|
45 joints
|
|
Hip Range of Motion (ROM)
Hip: 6 months- has full functional arc · No
|
81 joints
|
|
Hip Range of Motion (ROM)
Hip: 6 months- has full functional arc · Missing
|
7 joints
|
|
Hip Range of Motion (ROM)
Hip: 12 months- has full functional arc · Yes
|
32 joints
|
|
Hip Range of Motion (ROM)
Hip: 12 months- has full functional arc · No
|
42 joints
|
|
Hip Range of Motion (ROM)
Hip: 12 months- has full functional arc · Missing
|
4 joints
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
Full Range of Motion (ROM) defined as full functional arc in knee by the physician
Outcome measures
| Measure |
Safety Population
n=57 joints
All subjects enrolled into the study
|
|---|---|
|
Knee Range of Motion (ROM)
Knee: 6 months- has full functional arc · No
|
25 joints
|
|
Knee Range of Motion (ROM)
Knee: 6 months- has full functional arc · Missing
|
7 joints
|
|
Knee Range of Motion (ROM)
Knee: 12 months- has full functional arc · Yes
|
7 joints
|
|
Knee Range of Motion (ROM)
Knee: 12 months- has full functional arc · No
|
6 joints
|
|
Knee Range of Motion (ROM)
Knee: 12 months- has full functional arc · Missing
|
1 joints
|
|
Knee Range of Motion (ROM)
Knee: Screening - has full functional arc · Yes
|
28 joints
|
|
Knee Range of Motion (ROM)
Knee: Screening - has full functional arc · No
|
14 joints
|
|
Knee Range of Motion (ROM)
Knee: Screening - has full functional arc · Missing
|
15 joints
|
|
Knee Range of Motion (ROM)
Knee: 6 months- has full functional arc · Yes
|
24 joints
|
SECONDARY outcome
Timeframe: Screening, 6 months, and 12 monthsPopulation: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.
Outcome measures
| Measure |
Safety Population
n=118 joints
All subjects enrolled into the study
|
|---|---|
|
Shoulder Range of Motion (ROM)
Shoulder: Screening - has full functional arc · Yes
|
14 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: Screening - has full functional arc · No
|
100 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: Screening - has full functional arc · Missing
|
4 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 6 months- has full functional arc · Yes
|
24 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 6 months- has full functional arc · No
|
90 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 6 months- has full functional arc · Missing
|
1 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 12 months- has full functional arc · Yes
|
8 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 12 months- has full functional arc · No
|
16 joints
|
|
Shoulder Range of Motion (ROM)
Shoulder: 12 months- has full functional arc · Missing
|
3 joints
|
Adverse Events
Safety Population
Serious adverse events
| Measure |
Safety Population
n=294 participants at risk
All subjects enrolled into the study
|
|---|---|
|
Infections and infestations
Abcess of shoulder
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Biceps tear/tendon rupture
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Bone fracture
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
General disorders
Graves disease
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Hip pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Incomplete healing
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Knee Arthrofibrosis
|
0.68%
2/294 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Labral tear
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Recurrent rotator cuff tear
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
Congenital, familial and genetic disorders
Removal of screw
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rotator cuff and slap lesion repair
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Arthrofibrosis
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal cyst
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.34%
1/294 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Safety Population
n=294 participants at risk
All subjects enrolled into the study
|
|---|---|
|
General disorders
Abdominal pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
General disorders
Arm pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Back pain
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Clicking/popping sensation
|
1.4%
4/294 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Discoloration of foot
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema/rash
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Groin pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Groin stiffness/tightness
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Hematuria
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Hip pain
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Hip stiffness/tightness
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Implant pulled out of bone
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Inflammation
|
0.68%
2/294 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
2.7%
8/294 • Number of events 10 • 12 months
|
|
General disorders
Knee pain
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
General disorders
Leg pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar facet arthrosis
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Lymphedema
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
General disorders
Numbness/weakness
|
2.7%
8/294 • Number of events 8 • 12 months
|
|
General disorders
Pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Nervous system disorders
Patellar malalignment
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Recurrent shoulder instability
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Shoulder pain
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Shoulder subluxation
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Snapping Iliopsoas Tendon
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Spasms
|
0.68%
2/294 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Stiffness/tightness
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
General disorders
Withdrawal symptoms
|
0.34%
1/294 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.34%
1/294 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60