Suture Anchor Comparison in Rotator Cuff Repairs

NCT02350647 | Completed Results

• 1 other identifier: Pro00031426
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Rotator cuff; Ossification; Suture anchors

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Number of Participants With a Rotator Cuff Re-tear

  6 months

• Visual Analogue Pain Scale

  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)

  2 years

Study Arms (2)

HEALICOIL Regenesorb

EXPERIMENTAL

Suture anchor for rotator cuff repair

Device: Suture Anchor HEALOCOIL

Twinfix Ultra HA

ACTIVE COMPARATOR

Suture anchor for rotator cuff repair

Device: Suture anchor Twinfix Ultra HA

Interventions

Suture Anchor HEALOCOIL DEVICE

Rotator cuff tears will be repaired intraoperatively using suture anchors

HEALICOIL Regenesorb

Suture anchor Twinfix Ultra HA DEVICE

Twinfix Ultra HA

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Hawkins Foundation: lead

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Kyle Adams, Research Coordinator
• Organization: Hawkins Foundation

kyle.adams@hawkinsfoundation.com

864-454-7458

Study Officials

• Stefan Tolan, MD

  Steadman Hawkins Clinic of the Carolinas - Greenville Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: January 30, 2015
• Study Start: May 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 13, 2021
• Results First Posted: May 5, 2020

Record last verified: 2021-01

Locations

US (1)