NCT01987973

Brief Summary

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

4.8 years

First QC Date

November 9, 2013

Last Update Submit

March 7, 2022

Conditions

Rotator Cuff SyndromeRotator Cuff InjuryDisorder of Rotator CuffFull Thickness Rotator Cuff TearSkin Graft (Allograft) (Autograft) Failure

Outcome Measures

Primary Outcomes (1)

  • Western Ontario Rotator Cuff (WORC) Index

    A patient questionnaire evaluating shoulder pain, function.

    24 months

Study Arms (2)

Partial Repair / Debridement

ACTIVE COMPARATOR

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.

Procedure: Partial Rotator Cuff Repair

Allograft Reconstruction

EXPERIMENTAL

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"

Procedure: Partial Rotator Cuff Repair with Allograft Augmentation

Interventions

Partial Rotator Cuff RepairPROCEDURE

This is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated.

Also known as: Debridement
Partial Repair / Debridement
Partial Rotator Cuff Repair with Allograft AugmentationPROCEDURE

Patients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated.

Also known as: Human dermal allograft, Allograft Reconstruction
Allograft Reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Large/Massive rotator cuff tear \>3cm proven on MRI

You may not qualify if:

  • Non surgical candidate, unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E1, Canada

Location

Related Publications (1)

  • Wong I, Sparavalo S, King JP, Coady CM. Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Oct;49(12):3173-3183. doi: 10.1177/03635465211039846. Epub 2021 Sep 8.

    PMID: 34494901DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Debridement

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Ivan H Wong, MD FRCS(C)

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

November 9, 2013

First Posted

November 20, 2013

Study Start

February 1, 2015

Primary Completion

December 1, 2019

Study Completion

March 1, 2021

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)