Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessment of Healing Rates and Vascularity

NCT04361266 | Withdrawn

• 1 other identifier: STUDY19080165
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organized healing when Rotium is used, but there are no studies to confirm these outcomes translate to human population. Hypothesis: Rotium rotator cuff repairs will heal both quicker and better than traditional rotator cuff repair techniques.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Rotator Cuff Syndrome of Shoulder and Allied Disorders

Outcome Measures

Primary Outcomes (13)

• Rotator cuff integrity baseline/preoperative

  ultrasound assessment of rotator cuff

  preoperative

• Rotator cuff repair integrity @ 2 weeks

  ultrasound assessment of rotator cuff

  postoperative at 2 weeks

• Rotator cuff repair integrity @ 4 weeks

  ultrasound assessment of rotator cuff

  postoperative at 4 weeks

• Rotator cuff repair integrity @ 6 weeks

  ultrasound assessment of rotator cuff

  postoperative at 6 weeks

• Rotator cuff repair integrity @ 3 months

  ultrasound assessment of rotator cuff

  postoperative 3 months

• Rotator cuff repair integrity @ 6 months

  ultrasound assessment of rotator cuff

  postoperative at 6 months

• Rotator cuff repair integrity @ 12 months

  ultrasound assessment of rotator cuff

  postoperative at 12 months

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 2 weeks

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 4 weeks

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 6 weeks

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 3 months

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 6 months

• Postoperative rotator cuff vascularity during healing

  ultrasound assessment of rotator cuff at repair site using superb microvascular imaging (SMI)

  postoperative at 12 months

Secondary Outcomes (5)

• University California Los Angeles Shoulder score

  preoperative and postoperative at 6 weeks and 3,6,12 months postoperative

• Rowe score

  preoperative and postoperative at 6 weeks and 3,6,12 months postoperative

• Constant score

  preoperative and postoperative at 6 weeks and 3,6,12 months postoperative

• American shoulder and elbow surgeons score

  preoperative and postoperative at 6 weeks and 3,6,12 months postoperative

• SANE score

  preoperative and postoperative at 2,4, 6 weeks and 3,6,12 months postoperative

Other Outcomes (4)

• NSAID usage

  postoperative period @ 2,4, 6 weeks and 3, 6, 12 months

• Cortisone injections about the shoulder

  preoperative period

• Tobacco usage

  preoperative and postoperative periods @ 2,4, 6 weeks and 3, 6, 12 months

Study Arms (2)

Rotium patch recipient

EXPERIMENTAL

Subjects with Rotium nano scaffold patch included in rotator cuff repair construct

Device: Rotium nanoscaffold

Control

ACTIVE COMPARATOR

Subjects undergoing non-patch augmented rotator cuff repair

Procedure: Control arm rotator cuff repair

Interventions

Rotium nanoscaffold DEVICE

Rotium bioabsorbable nanoscaffold placed between bone-tendon interface of rotator cuff repair construct

Rotium patch recipient

Control arm rotator cuff repair PROCEDURE

Standard rotator cuff repair without Rotium

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic supraspinatus or supraspinatus and infraspinatus tear that can be repaired to the greater tuberosity in an anatomical manner using a dual layer repair technique.
• also included will be patients that have concomitant pathology addressed at time of surgery, specifically pathologies of the biceps tendon (tenodesis or tenotomy), arthrosis of the acromioclavicular joint (distal clavicle resection), or labral tearing (debridement or repair)
• included age range of subjects will be from 18-80 years old

You may not qualify if:

• diabetes, cancer or medical states that may impair healing, such as organ transplantation or systemic inflammatory process treated with immune modulating drugs (chemotherapy, immunosuppression drugs)
• prior surgery to the ipsilateral rotator cuff tendon
• need of soft tissue releases to accomplish an anatomic repair, partial repairs and/or concomitant subscapularis repair
• significant glenohumeral arthritis
• active or ongoing infection
• pregnancy

Sponsors & Collaborators

• Joshua Szabo, MD: lead
• Atreon Orthopedics: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinded ultrasound assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: prospective randomized control trial

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share