Trial Outcomes & Findings for PMCF Study on PEEK Suture Anchors for Hip Indications (NCT NCT03814044)

Last Updated: 2024-10-15

Results Overview

Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 (reintervention) on the index hip

Recruitment status

COMPLETED

Target enrollment

149 participants

Primary outcome timeframe

6 months

Results posted on

2024-10-15

Participant Flow

A total of 149 participants were enrolled in the study and 150 joints were observed.

Unit of analysis: joints

Participant milestones

Participant milestones
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Overall Study STARTED	149 150
Overall Study BIORAPTOR™ Knotless Suture Anchor	58 58
Overall Study SpeedLock Hip Suture Anchor	93 94
Overall Study COMPLETED	148 149
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Overall Study Protocol deviation	1

Baseline Characteristics

Data only available for 20 participants due to the retrospective nature of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n=150 joints Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Age, Continuous	38 years STANDARD_DEVIATION 11.9 • n=150 joints
Sex: Female, Male Female	105 joints n=150 joints
Sex: Female, Male Male	45 joints n=150 joints
Ethnicity (NIH/OMB) Hispanic or Latino	1 joints n=150 joints
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 joints n=150 joints
Ethnicity (NIH/OMB) Unknown or Not Reported	52 joints n=150 joints
Race/Ethnicity, Customized American Indian or Alaska Native · No	149 joints n=150 joints
Race/Ethnicity, Customized American Indian or Alaska Native · Yes	1 joints n=150 joints
Race/Ethnicity, Customized Asian · No	150 joints n=150 joints
Race/Ethnicity, Customized Asian · Yes	0 joints n=150 joints
Race/Ethnicity, Customized Black or African American · No	147 joints n=150 joints
Race/Ethnicity, Customized Black or African American · Yes	3 joints n=150 joints
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander · No	150 joints n=150 joints
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander · Yes	0 joints n=150 joints
Race/Ethnicity, Customized White · No	6 joints n=150 joints
Race/Ethnicity, Customized White · Yes	144 joints n=150 joints
Race/Ethnicity, Customized Other · No	147 joints n=150 joints
Race/Ethnicity, Customized Other · Yes	3 joints n=150 joints
Location of Device Implantation Left Hip	71 Participants n=149 Participants
Location of Device Implantation Right Hip	77 Participants n=149 Participants
Location of Device Implantation Bilaterally	1 Participants n=149 Participants
Duration of Surgery (min)	87.4 minutes STANDARD_DEVIATION 11.9 • n=20 Participants • Data only available for 20 participants due to the retrospective nature of the study.
Intervention Arthroscopic	150 joints n=150 joints
Intervention Open	0 joints n=150 joints
Intervention Unknown	0 joints n=150 joints
Duration of time from injury to surgery (days)	905.6 days STANDARD_DEVIATION 823.1 • n=86 Participants • Data only available for 86 participants due to the retrospective nature of the study.
Any Medical History Yes	95 joints n=150 joints
Any Medical History No	55 joints n=150 joints

PRIMARY outcome

Timeframe: 6 months

Population: Participants analyzed for each row indicate those with available retrospective data for the time frame \& outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n=149 Participants Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention BIORAPTOR™ Knotless Suture Anchor · Yes	58 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention BIORAPTOR™ Knotless Suture Anchor · No	0 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention SpeedLock Hip Suture Anchor · Yes	93 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention SpeedLock Hip Suture Anchor · No	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n=64 Participants Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention BIORAPTOR™ Knotless Suture Anchor · Yes	42 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention BIORAPTOR™ Knotless Suture Anchor · No	0 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention SpeedLock Hip Suture Anchor · Yes	24 Participants
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention SpeedLock Hip Suture Anchor · No	0 Participants

SECONDARY outcome

Timeframe: 6 and 12 months

Population: No data were collected at 6 months or 12 months for VAS pain score due to the retrospective nature of the study.

The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months 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.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n=106 Participants Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 6 months · Has full functional arc: Yes	18 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 6 months · Has full functional arc: No	10 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 6 months · Has full functional arc: Unknown	0 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 12 months · Has full functional arc: Yes	8 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 12 months · Has full functional arc: No	7 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc BIORAPTOR™ Knotless Suture Anchor: 12 months · Has full functional arc: Unknown	0 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 6 months · Has full functional arc: Yes	47 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 6 months · Has full functional arc: No	14 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 6 months · Has full functional arc: Unknown	17 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 12 months · Has full functional arc: Yes	4 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 12 months · Has full functional arc: No	4 Participants
Count of Participants With Range of Motion (ROM) Full Functional Arc SpeedLock Hip Suture Anchor: 12 months · Has full functional arc: Unknown	10 Participants

SECONDARY outcome

Timeframe: 6 and 12 months

Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care.

Outcome measures

Outcome measures
Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n=22 Participants Participants who have received PEEK Suture Anchors in the hip which included: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: Forward Flexion Angle (6 months)	97.5 degrees Standard Deviation 6.3
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: Internal Rotation Angle (6 months)	10.0 degrees Standard Deviation 0
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: External Rotation (6 months)	37.5 degrees Standard Deviation 10.6
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: Forward Flexion Angle (12 months)	102.9 degrees Standard Deviation 12.5
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: Internal Rotation Angle (12 months)	35.0 degrees Standard Deviation 7.1
Range of Motion (ROM) BIORAPTOR™ Knotless Suture Anchor: External Rotation (12 months)	40.0 degrees Standard Deviation 0
Range of Motion (ROM) SpeedLock Hip Suture Anchor: Forward Flexion Angle (6 months)	102.9 degrees Standard Deviation 31.8
Range of Motion (ROM) SpeedLock Hip Suture Anchor: Internal Rotation Angle (6 months)	27.5 degrees Standard Deviation 24.7
Range of Motion (ROM) SpeedLock Hip Suture Anchor: External Rotation (6 months)	35.0 degrees Standard Deviation 14.1
Range of Motion (ROM) SpeedLock Hip Suture Anchor: Forward Flexion Angle (12 months)	112.8 degrees Standard Deviation 11.7
Range of Motion (ROM) SpeedLock Hip Suture Anchor: Internal Rotation Angle (12 months)	16.0 degrees Standard Deviation 8.5
Range of Motion (ROM) SpeedLock Hip Suture Anchor: External Rotation (12 months)	38.5 degrees Standard Deviation 9.2

Adverse Events

BIORAPTOR™ Knotless Suture Anchor

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

SpeedLock Hip Suture Anchor

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BIORAPTOR™ Knotless Suture Anchor n=58 participants at risk Participants who have received PEEK Suture Anchors in the hip: BIORAPTOR™ Knotless Suture Anchor	SpeedLock Hip Suture Anchor n=93 participants at risk Participants who have received PEEK Suture Anchors in the hip: SpeedLock Hip Suture Anchor
Blood and lymphatic system disorders STROKE	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.1% 1/93 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Musculoskeletal and connective tissue disorders POST SURGICAL RIGHT HIP OSTEOARTHRITIS	1.7% 1/58 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/93 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications REPEAT LEFT HIP LABRAL TEAR	1.7% 1/58 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/93 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Musculoskeletal and connective tissue disorders RIGHT PSOAS TENDONITIS/SNAP	1.7% 1/58 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/93 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications LEFT HIP LABRAL ACETABULAR RETEAR	1.7% 1/58 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/93 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications LEFT HIP LABRAL RETEAR	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.1% 1/93 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications RIGHT HIP LABRAL TEAR	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.1% 1/93 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders LEFT HIP INTRA-ARTICULAR PAIN	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	1.1% 1/93 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
Injury, poisoning and procedural complications HIP LABRAL TEAR	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	2.2% 2/93 • Number of events 2 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).

Other adverse events

Other adverse events
Measure	BIORAPTOR™ Knotless Suture Anchor n=58 participants at risk Participants who have received PEEK Suture Anchors in the hip: BIORAPTOR™ Knotless Suture Anchor	SpeedLock Hip Suture Anchor n=93 participants at risk Participants who have received PEEK Suture Anchors in the hip: SpeedLock Hip Suture Anchor
Musculoskeletal and connective tissue disorders ILIOPSOAS TENDENOPATHY	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	7.5% 7/93 • Number of events 7 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders RIGHT LEG PAIN	1.7% 1/58 • Number of events 1 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	0.00% 0/93 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
General disorders HIP PAIN	0.00% 0/58 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).	4.3% 4/93 • Number of events 4 • Surgery to End of Study (EOS) visit, approximately 12 months AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 149 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).

Additional Information

Judith Horner

Smith + Nephew, Inc.

Phone: +44 1482 673251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60