Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff

NCT01767740 | Completed DMC

• 1 other identifier: 15001105
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff repair.

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff Tear; Supraspinatus Tear

Outcome Measures

Primary Outcomes (1)

• Rotator Cuff Integrity

  The primary endpoint of the 6-month postoperative analysis is to assess rotator cuff integrity at 6 months, defined as the proportion of subjects with a re-tear of the rotator cuff as measured by high-resolution ultrasound.

  6 months post-operatively

Secondary Outcomes (8)

• Rotator Cuff Integrity

  1, 3 and 6 weeks and 3 and 12 months post-operatively

• Change in post-surgery tissue thickness, rotator cuff integrity, tendon echogenicity and muscle atrophy

  1, 3 and 6 weeks and 3, 6 and 12 months post-operatively

• Change in Vascularity

  1, 3 and 6 weeks and 3, 6 and 12 months post-operatively

• Change in Constant Shoulder Assessment

  1, 3 and 6 weeks and 3, 6 and 12 months post-operatively

• Change in Western Ontario Rotator Cuff Index

  1, 3 and 6 weeks and 3, 6 and 12 months post-operatively

Study Arms (2)

ULTRABRAID PLUS SUTURE

EXPERIMENTAL

ULTRABRAID Plus Suture manufactured by Smith \& Nephew used in subjects undergoing rotator cuff repair.

Device: ULTRABRAID PLUS SUTURE

ULTRABRAID SUTURE

ACTIVE COMPARATOR

ULTRABRAID Suture is a marketed suture manufactured by Smith \& Nephew used in subjects undergoing rotator cuff repair.

Device: ULTRABRAID SUTURE

Interventions

ULTRABRAID PLUS SUTURE DEVICE

Rotator Cuff Repair with ULTRABRAID PLUS SUTURE

ULTRABRAID PLUS SUTURE

ULTRABRAID SUTURE DEVICE

Rotator Cuff Repair with ULTRABRAID SUTURE

ULTRABRAID SUTURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 70 years at the time of surgery
• Willing and able to give voluntary informed consent to participate in this investigation
• Small (\<1cm), Medium (1-3cm) or large (\>3-5cm) tear of the supraspinatus tendon, which may or may not include the infraspinatus tendon of the rotator cuff. Tear size will be based on area of longest dimension as evidenced by clinical examination and diagnostic imaging prior to surgery, with the definitive measurement confirmed at surgery
• Tear requires repair within two years 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 physical therapy and all post-operative study visits

You may not qualify if:

• Tears involving tendons other than the supraspinatus and infraspinatus
• Partial thickness tears of the rotator cuff (tear must be full thickness)
• 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.
• Subject has a known sensitivity to implant materials, including sodium butyrate.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (4)

Innovation Science and Medicine

Burlington, Ontario, L7R 4C7, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

St. Josephs Hospital

London, Ontario, N6A 4L6, Canada

Location

Women's College Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Sutures

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Robert Litchfield, MD, FRCSC

  Fowler Kennedy Sports Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 14, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

CA (4)