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PMCF Study on PEEK Suture Anchors for Shoulder Indications
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Summary Quick facts Who can join Endpoints Results Adverse events Related trials Sources
Completed
Results posted
Last updated 12 April 2022
What this trial tests
trial testing Polyetheretherketone (PEEK) Shoulder Suture Anchors in Soft Tissue to Bone Fixation in 464 participants. Completed in 28 August 2019.
Timeline
14 February 2019
Primary endpoint
28 August 2019
Quick facts
Lead sponsor Smith & Nephew, Inc. Status Completed Study type OBSERVATIONAL Enrollment 464 Start date 14 February 2019 Primary completion 28 August 2019 Estimated completion 28 August 2019 Sites 11 locations across United States
Drugs / interventions tested
Polyetheretherketone (PEEK) Shoulder Suture Anchors
Conditions studied
Sponsor
Smith & Nephew, Inc.
Who can join
18 and older, any sex, with Soft Tissue to Bone Fixation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
Primary
· 6 months
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
* no inflammatory or allergic response
* no device-related adverse event (AE)
* no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
HEALICOIL™ PK Preloaded Suture Anchors
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 185 Polyetheretherketone (PEEK) Shoulder Suture Anchors 6
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 38 Polyetheretherketone (PEEK) Shoulder Suture Anchors 3
MULTIFIX™ S Ultra Knotless Fixation System
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 71 Polyetheretherketone (PEEK) Shoulder Suture Anchors 6
FOOTPRINT™ Ultra PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 128 Polyetheretherketone (PEEK) Shoulder Suture Anchors 3
TWINFIX™ Ultra PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 57 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
SPEEDSCREW™ Knotless Fixation System
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 58 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
SpeedLock Knotless Fixation Device
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 18 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
Secondary
· 12 months
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
* no inflammatory or allergic response
* no device-related adverse event (AE)
* no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
HEALICOIL™ PK Preloaded Suture Anchors
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 50 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 5 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
MULTIFIX™ S Ultra Knotless Fixation System
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 17 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
FOOTPRINT™ Ultra PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 16 Polyetheretherketone (PEEK) Shoulder Suture Anchors 2
TWINFIX™ Ultra PK Suture Anchor
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 6 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
SPEEDSCREW™ Knotless Fixation System
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 4 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
SpeedLock Knotless Fixation Device
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
Visual Analog Scale (VAS) - Pain
Secondary
· 6 and 12 months
The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
HEALICOIL™ PK Preloaded Suture Anchors: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 1.8 ± 2.1
HEALICOIL™ PK Preloaded Suture Anchors: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2.4 ± 1.8
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2.5 ± 2.8
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 4.5 ± 0.7
MULTIFIX™ S Ultra Knotless Fixation System: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2.2 ± 2.1
MULTIFIX™ S Ultra Knotless Fixation System: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2.3 ± 1.9
FOOTPRINT™ Ultra PK Suture Anchor: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 2.3 ± 2.1
Count of Participants With Range of Motion (ROM) Full Functional Arc
Secondary
· 6 and 12 months
Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
HEALICOIL™ PK Preloaded Suture Anchors: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 111 Polyetheretherketone (PEEK) Shoulder Suture Anchors 48 Polyetheretherketone (PEEK) Shoulder Suture Anchors 4
HEALICOIL™ PK Preloaded Suture Anchors: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 37 Polyetheretherketone (PEEK) Shoulder Suture Anchors 10 Polyetheretherketone (PEEK) Shoulder Suture Anchors 2
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 29 Polyetheretherketone (PEEK) Shoulder Suture Anchors 3 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 1 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
MULTIFIX™ S Ultra Knotless Fixation System: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 35 Polyetheretherketone (PEEK) Shoulder Suture Anchors 12 Polyetheretherketone (PEEK) Shoulder Suture Anchors 4
MULTIFIX™ S Ultra Knotless Fixation System: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 9 Polyetheretherketone (PEEK) Shoulder Suture Anchors 7 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
FOOTPRINT™ Ultra PK Suture Anchor: 6 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 90 Polyetheretherketone (PEEK) Shoulder Suture Anchors 14 Polyetheretherketone (PEEK) Shoulder Suture Anchors 1
FOOTPRINT™ Ultra PK Suture Anchor: 12 months
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 17 Polyetheretherketone (PEEK) Shoulder Suture Anchors 2 Polyetheretherketone (PEEK) Shoulder Suture Anchors 0
Range of Motion (ROM)
Secondary
· 6 and 12 months
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 157 ± 20.2
HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 25.7 ± 40.6
HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 49.3 ± 20.5
HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 141.1 ± 39.8
HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 75 ± 21.2
HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 59.4 ± 25.7
BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 89 ± 100.4
BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months)
Group Value 95% CI Polyetheretherketone (PEEK) Shoulder Suture Anchors 60 ± 15
Adverse events — posted to ClinicalTrials.gov
Time frame: Surgery to End of Study (EOS) visit, approximately 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
HEALICOIL™ PK Preloaded Suture Anchors
Serious: 15/193 (8%)
Deaths: 0/193
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
Serious: 7/41 (17%)
Deaths: 0/41
MULTIFIX™ S Ultra Knotless Fixation System
Serious: 13/78 (17%)
Deaths: 0/78
FOOTPRINT™ Ultra PK Suture Anchors
Serious: 10/136 (7%)
Deaths: 0/136
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles
Serious: 1/57 (2%)
Deaths: 0/57
SPEEDSCREW™ Knotless Fixation System
Serious: 4/59 (7%)
Deaths: 0/59
SpeedLock Knotless Fixation Device
Serious: 0/18 (0%)
Deaths: 0/18
Serious adverse events (36 terms) Reaction System HEALICOIL™ PK Preloaded Su… BIORAPTOR™ 2.3 PK Suture A… MULTIFIX™ S Ultra Knotless… FOOTPRINT™ Ultra PK Suture… TWINFIX™ Ultra PK Suture A… SPEEDSCREW™ Knotless Fixat… SpeedLock Knotless Fixatio… RE-TEAR OF ROTATOR CUFF Injury, poisoning and procedural complications — — — — — — — LEFT SHOULDER ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders — — — — — — — RECURRENT RTC TEAR Musculoskeletal and connective tissue disorders — — — — — — — ADHESIVE CAPSULITIS IN RIGHT SHOULDER Musculoskeletal and connective tissue disorders — — — — — — — PULMONARY EMBOLUS Blood and lymphatic system disorders — — — — — — — RIGHT CARPAL TUNNEL WITH RELEASE Nervous system disorders — — — — — — — LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR Injury, poisoning and procedural complications — — — — — — — R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME Injury, poisoning and procedural complications — — — — — — — RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT Injury, poisoning and procedural complications — — — — — — — LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR General disorders — — — — — — — DECREASED ROM RIGHT SHOULDER Musculoskeletal and connective tissue disorders — — — — — — — RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR General disorders — — — — — — — CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM Musculoskeletal and connective tissue disorders — — — — — — — LEFT SHOULDER PAIN AND DECREASED ROM Musculoskeletal and connective tissue disorders — — — — — — — R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR General disorders — — — — — — — RIGHT SHOULDER ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders — — — — — — — R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY Musculoskeletal and connective tissue disorders — — — — — — — LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR General disorders — — — — — — — RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR Musculoskeletal and connective tissue disorders — — — — — — — FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR General disorders — — — — — — — LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR General disorders — — — — — — — R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR, General disorders — — — — — — — RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR, General disorders — — — — — — — INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN General disorders — — — — — — — WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR General disorders — — — — — — —
Other adverse events (162 terms — click to expand) Reaction System HEALICOIL™ PK Preloaded Su… BIORAPTOR™ 2.3 PK Suture A… MULTIFIX™ S Ultra Knotless… FOOTPRINT™ Ultra PK Suture… TWINFIX™ Ultra PK Suture A… SPEEDSCREW™ Knotless Fixat… SpeedLock Knotless Fixatio… SHOULDER PAIN General disorders — — — — — — — CONTINUING SHOULDER PAIN General disorders — — — — — — — OCCASIONAL SHOULDER PAIN General disorders — — — — — — — ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER Injury, poisoning and procedural complications — — — — — — — LEFT LATERAL EPICONDYLITIS Musculoskeletal and connective tissue disorders — — — — — — — RECURRENT RTC TEAR Injury, poisoning and procedural complications — — — — — — — COMPLEX REGIONAL PAIN SYNDROME TYPE II General disorders — — — — — — — PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA. General disorders — — — — — — — RIGHT SIDE ARM PAIN General disorders — — — — — — — SHOULDER PAIN POST FALL General disorders — — — — — — — LEFT HAND NUMBNESS General disorders — — — — — — — LEFT SHOULDER TENDINITIS/BURSITIS Musculoskeletal and connective tissue disorders — — — — — — — RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL Injury, poisoning and procedural complications — — — — — — — ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders — — — — — — — LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS Skin and subcutaneous tissue disorders — — — — — — — RIGHT SHOULDER PAIN General disorders — — — — — — — CONTINUED LEFT SHOULDER WEAKNESS General disorders — — — — — — — ACTIVE RANGE OF MOTION LIMITED BY PAIN General disorders — — — — — — — BICEPS ATROPHY Musculoskeletal and connective tissue disorders — — — — — — — SHOOTING PAIN DOWN LEFT ARM General disorders — — — — — — — RIGHT HAND CONTUSION General disorders — — — — — — — ADHESIVE CAPSULITIS RIGHT SHOULDER Musculoskeletal and connective tissue disorders — — — — — — — INCREASE IN RIGHT SHOULDER PAIN General disorders — — — — — — — NEW ONSET ATRIAL FIBRILLATION Cardiac disorders — — — — — — — RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY General disorders — — — — — — — RIGHT BICEPS TENDONITIS Musculoskeletal and connective tissue disorders — — — — — — — RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR Musculoskeletal and connective tissue disorders — — — — — — — PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY Musculoskeletal and connective tissue disorders — — — — — — — BILATERAL SHOULDER PAIN General disorders — — — — — — — LEFT SHOULDER INCREASING PAIN General disorders — — — — — — — LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS General disorders — — — — — — — NIGHTMARES FROM PERCOCET Psychiatric disorders — — — — — — — INSOMNIA R/T LEFT SHOULDER PAIN General disorders — — — — — — — LEFT SHOULDER PAIN WITH EXERCISING General disorders — — — — — — — LEFT SHOULDER STIFFNESS General disorders — — — — — — — LEFT SHOULDER SORENESS General disorders — — — — — — — EXACERBATION HYPERTENSION Vascular disorders — — — — — — — BICEPS TENDONITIS RIGHT SHOULDER Musculoskeletal and connective tissue disorders — — — — — — — NUMBNESS RIGHT THUMB General disorders — — — — — — — HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN General disorders — — — — — — —
Most-reported serious reactions: RE-TEAR OF ROTATOR CUFF , LEFT SHOULDER ADHESIVE CAPSULITIS , RECURRENT RTC TEAR , ADHESIVE CAPSULITIS IN RIGHT SHOULDER , PULMONARY EMBOLUS , RIGHT CARPAL TUNNEL WITH RELEASE , LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR , R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME .
Data from ClinicalTrials.gov NCT03826667 adverse events section .
Sponsor's own description
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT03826667 (US National Library of Medicine, public domain)Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Smith & Nephew, Inc.Last refreshed : 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03826667.
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