Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

NCT01877772 | Completed

• 1 other identifier: 2013-0211
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. The control group will undergo the standard repair for rotator cuff tears. It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.

Conditions

Rotator Cuff Tear

Keywords

cuff repair; arthroscopic; Trephination; Bone; cuff tear

Outcome Measures

Primary Outcomes (1)

• High-resolution ultrasound

  High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI. The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively.

  6 and 24 months post op

Secondary Outcomes (1)

• Functional Outcome scores

  baseline and 3, 6, 12, 18 and 24 months post op

Study Arms (2)

Bone Trephination

ACTIVE COMPARATOR

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

Procedure: Bone Trephination; Procedure: Control

Control

ACTIVE COMPARATOR

The control group will undergo standard rotator cuff repair.

Procedure: Control

Interventions

Bone Trephination PROCEDURE

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

Bone Trephination

Control PROCEDURE

The control group will undergo standard rotator cuff repair.

Bone Trephination; Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
• Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
• The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
• Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
• Activity modification
• Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.

You may not qualify if:

• Characteristics of the cuff tear that render the cuff irrepairable:
• fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
• Partial thickness cuff tears.
• Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
• Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
• Isolated subscapularis tendon tears
• Active joint or systemic infection
• Significant muscle paralysis
• Rotator cuff tear arthropathy
• Charcot's arthropathy
• Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
• Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
• Unable to speak or read English/French
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for 24 months

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Panam Clinic: collaborator
• London Health Sciences Centre: collaborator
• University of Alberta: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (2)

• Zhao S, Liu G, Zhang D, Tang S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: Letter to the Editor. Am J Sports Med. 2023 Jun;51(7):NP20. doi: 10.1177/03635465231169536. No abstract available.

  PMID: 37259789 DERIVED

• Lapner P, Bouliane M, Pollock JW, Coupal S, Sabri E, Hodgdon T, Old J, Mcilquham K, MacDonald P; CSES Investigators:; Stranges G, Berdusco R, Marsh J, Dubberley J, McRae S. Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Feb;51(2):323-330. doi: 10.1177/03635465221138562. Epub 2022 Dec 1.

  PMID: 36453726 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Peter Lapner, MD

  OHRI

  PRINCIPAL INVESTIGATOR

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: June 12, 2013
• First Posted: June 14, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

CA (1)