Instability, Joint
Conditions
Keywords
Suturefix, hip instability, shoulder instability
Brief summary
The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
Detailed description
Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement, stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%. Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage.
Interventions
DEVICESUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
Fixation device intended to provide secure fixation of soft tissue to bone
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has consented to participate in the study by signing the EC-approved informed consent form * Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor * Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding * Hip subjects only: * FAI (Femoroacetabular Impingement) * Shoulder subjects only: * Subject with a history of recurrent dislocation/subluxation of the shoulder
Exclusion criteria
* Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative) * Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures * Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation * Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation * Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture * Comminuted bone surface, which would compromise secure anchor fixation * Hip subjects only: * Dysplasia latera/central less than 20° * Shoulder subjects only: * Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success at 6 Months | 6 month post-surgery | Number of participants without signs of failure and/or re-intervention as assessed by the surgeon. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative Anchor Deployment Success | Intraoperatively | Number of suture anchors that were successfully deployed to bone, soft tissues, or both. |
| Intraoperative Suture Anchor Failure | Intraoperatively | Suture anchor failures categorized by number of participants with: * Intra-operative failures (Yes/No) * Anchors pulled out (Yes/No) * Additional anchors used as a result of failure (Yes/No) |
| Device-related Re-Intervention | 12 months | Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE. |
| Visual Analog Scale (VAS) Pain Score - All Participants | 6 and 12 months postoperative | Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. |
| Visual Analog Scale (VAS) Satisfaction Score - All Participants | 6 and 12 months postoperative | Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. |
| Clinical Success at 12 Months | 12 months post-operative | Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon. |
| Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 and 12 months postoperative | The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport & Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms. |
| Modified Harris Hip Score (mHHS) - Hip Participants | Preoperative, 6 and 12 months Postoperative | The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows: * \<70 (poor result) * 70-79 (fair result) * 80-89 (good result) * \>90 (excellent result) This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. |
| Rowe Score - Shoulder Participants | 6 and 12 months postoperative | The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. |
| American Shoulder and Elbow Surgeons Score - Shoulder Participants | 6 and 12 months postoperative | The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition |
| Constant-Murley Shoulder Scores (CMS) - Shoulder Participants | 6 months and 12 months Postoperative | The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability). |
| Analysis of EQ-5D-5L Index - All Participants | 6 months and 12 months postoperative | The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference. |
Countries
Denmark, Finland, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled form 07 November 2018 to 21 May 2021.
Pre-assignment details
Overall, 83 participants (42 hips / 41 shoulders) were enrolled and received the investigational product (IP) at 9 sites.
Participants by arm
| Arm | Count |
|---|---|
| Arthroscopic Hip and Shoulder Repair SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor: Fixation device intended to provide secure fixation of soft tissue to bone | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Sponsor terminated study | 2 |
Baseline characteristics
| Characteristic | Arthroscopic Hip and Shoulder Repair |
|---|---|
| Age, Continuous | 32.70 years STANDARD_DEVIATION 10.95 |
| Body Mass Index (BMI) | 24.40 kg/m^2 STANDARD_DEVIATION 3.52 |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black | 2 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 78 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 83 |
| other Total, other adverse events | 13 / 83 |
| serious Total, serious adverse events | 4 / 83 |
Outcome results
Primary
Clinical Success at 6 Months
Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.
Time frame: 6 month post-surgery
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Clinical Success at 6 Months | 56 Participants |
Secondary
American Shoulder and Elbow Surgeons Score - Shoulder Participants
The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition
Time frame: 6 and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | American Shoulder and Elbow Surgeons Score - Shoulder Participants | 6 Months Postoperative | 91.0 score on a scale | Standard Deviation 12.15 |
| Arthroscopic Hip and Shoulder Repair | American Shoulder and Elbow Surgeons Score - Shoulder Participants | 12 Months Postoperative | 95.7 score on a scale | Standard Deviation 7.99 |
Secondary
Analysis of EQ-5D-5L Index - All Participants
The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Time frame: 6 months and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Analysis of EQ-5D-5L Index - All Participants | 12 Months Postoperative | 0.9 score on a scale | Standard Deviation 0.2 |
| Arthroscopic Hip and Shoulder Repair | Analysis of EQ-5D-5L Index - All Participants | 6 Months Postoperative | 0.8 score on a scale | Standard Deviation 0.22 |
Secondary
Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants
The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport & Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms.
Time frame: 6 and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 Months Postoperative: Symptoms | 74.5 score on a scale | Standard Deviation 23.57 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 12 Months Postoperative: Daily Living | 84.0 score on a scale | Standard Deviation 21.1 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 Months Postoperative: Pain | 77.8 score on a scale | Standard Deviation 22.87 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 Months Postoperative: Daily Living | 85.1 score on a scale | Standard Deviation 20.72 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 Months Postoperative: Sports and Recreation | 71.3 score on a scale | Standard Deviation 26.34 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 6 Months Postoperative: Quality of Life | 64.2 score on a scale | Standard Deviation 28.33 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 12 Months Postoperative: Symptoms | 75.7 score on a scale | Standard Deviation 23.08 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 12 Months Postoperative: Pain | 78.6 score on a scale | Standard Deviation 20.72 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 12 Months Postoperative: Sports and Recreation | 72.3 score on a scale | Standard Deviation 29.21 |
| Arthroscopic Hip and Shoulder Repair | Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants | 12 Months Postoperative: Quality of Life | 64.5 score on a scale | Standard Deviation 28.79 |
Secondary
Clinical Success at 12 Months
Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.
Time frame: 12 months post-operative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Clinical Success at 12 Months | 64 Participants |
Secondary
Constant-Murley Shoulder Scores (CMS) - Shoulder Participants
The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability).
Time frame: 6 months and 12 months Postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Constant-Murley Shoulder Scores (CMS) - Shoulder Participants | 6 Months Postoperative | 77.9 score on a scale | Standard Deviation 5.95 |
| Arthroscopic Hip and Shoulder Repair | Constant-Murley Shoulder Scores (CMS) - Shoulder Participants | 12 Months Postoperative | 79.8 score on a scale | Standard Deviation 3.63 |
Secondary
Device-related Re-Intervention
Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.
Time frame: 12 months
Population: Participants from the Safety Population (SAF) utilized for this assessment. SAF included participants that received the investigational product (IP). Additionally, this assessment only included participants from the SAF population with a device-related adverse event (AE).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Device-related Re-Intervention | 1 Participants |
Secondary
Intra-operative Anchor Deployment Success
Number of suture anchors that were successfully deployed to bone, soft tissues, or both.
Time frame: Intraoperatively
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Intra-operative Anchor Deployment Success | 73 suture anchors |
Secondary
Intraoperative Suture Anchor Failure
Suture anchor failures categorized by number of participants with: * Intra-operative failures (Yes/No) * Anchors pulled out (Yes/No) * Additional anchors used as a result of failure (Yes/No)
Time frame: Intraoperatively
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with additional anchors used as a result of failure | Yes | 5 Participants |
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with intra-operative failures | Yes | 6 Participants |
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with intra-operative failures | No | 67 Participants |
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with anchors pulled out | Yes | 4 Participants |
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with anchors pulled out | No | 25 Participants |
| Arthroscopic Hip and Shoulder Repair | Intraoperative Suture Anchor Failure | Participants with additional anchors used as a result of failure | No | 23 Participants |
Secondary
Modified Harris Hip Score (mHHS) - Hip Participants
The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows: * \<70 (poor result) * 70-79 (fair result) * 80-89 (good result) * \>90 (excellent result) This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Time frame: Preoperative, 6 and 12 months Postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Modified Harris Hip Score (mHHS) - Hip Participants | Preoperative | 51.3 score on a scale | Standard Deviation 17.13 |
| Arthroscopic Hip and Shoulder Repair | Modified Harris Hip Score (mHHS) - Hip Participants | 6 Months Postoperative | 71.2 score on a scale | Standard Deviation 19.24 |
| Arthroscopic Hip and Shoulder Repair | Modified Harris Hip Score (mHHS) - Hip Participants | 12 Months Postoperative | 71.9 score on a scale | Standard Deviation 17.88 |
Secondary
Rowe Score - Shoulder Participants
The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Time frame: 6 and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified..
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Rowe Score - Shoulder Participants | 6 Months Postoperative | 93.3 score on a scale | Standard Deviation 11.54 |
| Arthroscopic Hip and Shoulder Repair | Rowe Score - Shoulder Participants | 12 Months Postoperative | 97.9 score on a scale | Standard Deviation 8.54 |
Secondary
Visual Analog Scale (VAS) Pain Score - All Participants
Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Time frame: 6 and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Visual Analog Scale (VAS) Pain Score - All Participants | 6 Months Postoperative | 2.0 score on a scale | Standard Deviation 2.38 |
| Arthroscopic Hip and Shoulder Repair | Visual Analog Scale (VAS) Pain Score - All Participants | 12 Months Postoperative | 1.0 score on a scale | Standard Deviation 1.8 |
Secondary
Visual Analog Scale (VAS) Satisfaction Score - All Participants
Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.
Time frame: 6 and 12 months postoperative
Population: Participants from the Full Analysis Set (FAS) utilized for this assessment. Population included participants with available data that were enrolled into the study and attended at least one post-Baseline assessment for the time frames specified..
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopic Hip and Shoulder Repair | Visual Analog Scale (VAS) Satisfaction Score - All Participants | 6 Months Postoperative | 2.30 score on a scale | Standard Deviation 3.26 |
| Arthroscopic Hip and Shoulder Repair | Visual Analog Scale (VAS) Satisfaction Score - All Participants | 12 Months Postoperative | 1.0 score on a scale | Standard Deviation 1.81 |