Rotator Cuff InjuryNCT02350647
Suture Anchor Comparison in Rotator Cuff Repairs
A study testing Suture Anchor HEALOCOIL and Suture anchor Twinfix Ultra HA in people with Rotator Cuff Injury, run by The Hawkins Foundation at 1 site in United States.
Trial summary
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Suture Anchor HEALOCOIL and Suture anchor Twinfix Ultra HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 35 to 75 years at the time of surgery.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Full thickness tear of the rotator cuff
- Tear requires repair within one year of initial diagnosis.
- Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity).
- Willing and able, in the opinion of the Investigator, to cooperate with study procedures, and willing to return to study site for all required post-operative study visits.
Who cannot join
- Evidence of acute trauma including fracture or dislocation of the shoulder joint.
- Chronic retraction.
- Evidence of active infection, osteomyelitis, sepsis or distant infection, which could spread to the index joint.
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder.
- Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date.
- Evidence of osteomalacia or other metabolic bone disorder(s), which may impair bone or soft tissue function.
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- Evidence of other significant shoulder pathology including (Type II-IV lesion, Bankart lesion, Hill Sachs lesion).
- Patient has grade 4 changes to articular cartilage in operative shoulder
- Inflammatory arthropathies.
- Significant muscle paralysis of the shoulder girdle.
- Painful pathologies of the cervical spine.
- Comminuted bone surface, which would compromise secure anchor fixation.
- Non-surgical rotator cuff associated treatment, such as corticosteroid injection, within one (1) month prior to scheduled surgery date.
- Participating in another investigational trial or ongoing study that would interfere with the assessment of the primary and secondary outcomes.
- Female patient who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
- Major psychiatric illness, developmental handicap or inability to read and understand the English language.
- Major medical illness that would preclude undergoing surgery.
- Known to be involved in any active injury litigation claims relating to the study shoulder.
- Unwilling or unable to be assessed according to study protocol for two years following surgery.
- Patient requires a concomitant SLAP repair procedure in operative shoulder.
- Surgeon plans to use a Platelet Rich Plasma product or another therapy intended to augment healing of the rotator cuff in the study procedure.
- Protocol specified surgical technique cannot be followed for this subject.
- Rotator cuff repair will be done via open (as opposed to arthroscopic) procedure.
- Any other reason (in the judgment of the investigator).
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
About this study
Official title: TWO-ARM, SINGLE BLIND, RANDOMIZED POST-MARKET STUDY ON THE USE OF HEALICOIL™ REGENESORB SUTURE ANCHOR IN THE REPAIR OF TEARS OF THE ROTATOR CUFF
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
- Conditions
- Rotator Cuff Injury
- Being tested
- Suture Anchor HEALOCOIL, Suture anchor Twinfix Ultra HA
- Keywords
- Rotator cuff, Ossification, Suture anchors
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture Anchor HEALOCOILDevice
Rotator cuff tears will be repaired intraoperatively using suture anchors
Suture anchor Twinfix Ultra HADevice
| Study group | Role | What they receive |
|---|---|---|
| HEALICOIL Regenesorb | Experimental | Suture anchor for rotator cuff repair Receives: Device: Suture Anchor HEALOCOIL |
| Twinfix Ultra HA | Active comparator | Suture anchor for rotator cuff repair Receives: Device: Suture anchor Twinfix Ultra HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ossification Quality Score (Bony Ingrowth Assessed Via CT)
The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects "little or no bone ossification", Quality score 2 reflects "Some ossification; discontinuous or with a wide lucent rim", Quality score 3 reflects "Ossification with a thin lucent rim", and Quality score 4 reflects "Good ossification; border of tract vague". For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification).
The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification.
Measured: 2 years
Secondary outcomes (3)
Number of Participants With a Rotator Cuff Re-tear
Repair failure rate (Defined as number of subjects with a re-tear) determined by ultrasound 6 months after surgery.
Measured: 6 months
Visual Analogue Pain Scale
The Visual Analogue Pain Scale (VAS) measures the patient-reported level of pain at the two-year follow-up. The scale runs from 0 to 10, with "0" indicating no pain and "10" indicating extreme pain. The lower the VAS Pain level, the better the outcome in regards to level of pain.
Measured: 2 years
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D)
Outcomes at Two Years on the following:
- Western Ontario Rotator Cuff Index (WORC): developed to help understand the particular signs, symptoms, and functional limitations associated with rotator cuff tendinopathy. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst.
- PENN Shoulder Score (PENN): The PENN is a 100-point shoulder-specific self-report questionnaire evaluating pain, satisfaction, and shoulder function. The outcome is measured on a scale of 0 to 100, with 100 being the best outcome and 0 being the worst.
- Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.
- Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Tolan, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350647
- Sponsor's protocol ID
- Pro00031426
- Status last verified
- Jan 2021
- First submitted
- 10 Sep 2014
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TWO-ARM, SINGLE BLIND, RANDOMIZED POST-MARKET STUDY ON THE USE OF HEALICOIL™ REGENESORB SUTURE ANCHOR IN THE REPAIR OF TEARS OF THE ROTATOR CUFF
- ClinicalTrials.gov ID
- NCT02350647
- Acronym / sponsor ID
- Pro00031426
- Conditions
- Rotator Cuff Injury
- Keywords
- Rotator cuff, Ossification, Suture anchors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 5 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALICOIL Regenesorb | Experimental | Device: Suture Anchor HEALOCOILSuture anchor for rotator cuff repair |
| Twinfix Ultra HA | Active comparator | Device: Suture anchor Twinfix Ultra HASuture anchor for rotator cuff repair |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 35 to 75 years at the time of surgery.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Full thickness tear of the rotator cuff
- Tear requires repair within one year of initial diagnosis.
- Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity).
Key exclusion criteria (24 listed)
- Evidence of acute trauma including fracture or dislocation of the shoulder joint.
- Chronic retraction.
- Evidence of active infection, osteomyelitis, sepsis or distant infection, which could spread to the index joint.
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder.
- Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture Anchor HEALOCOILRotator cuff tears will be repaired intraoperatively using suture anchors | Device | HEALICOIL Regenesorb |
| Suture anchor Twinfix Ultra HA | Device | Twinfix Ultra HA |
Primary outcome
Ossification Quality Score (Bony Ingrowth Assessed Via CT)
Time frame: 2 years
The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects "little or no bone ossification", Quality score 2 reflects "Some ossification; discontinuous or with a wide lucent rim", Quality score 3 reflects "Ossification with a thin lucent rim", and Quality score 4 reflects "Good ossification; border of tract vague". For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification). The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification.
3 secondary outcomes
Number of Participants With a Rotator Cuff Re-tear
Time frame: 6 months
Visual Analogue Pain Scale
Time frame: 2 years
Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Tolan, MD principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture Anchor HEALOCOIL and Suture anchor Twinfix Ultra HA in people with Rotator Cuff Injury, run by The Hawkins Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ossification Quality Score (Bony Ingrowth Assessed Via CT) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.