NCT03362320

Brief Summary

Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 18, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

November 16, 2017

Last Update Submit

July 11, 2020

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Retear rate

    Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups

    12 months postoperatively

Secondary Outcomes (11)

  • Constant-Murley score

    baseline, 24 and 60 months postoperatively

  • Range of motion (ROM)

    baseline, 24 and 60 months postoperatively

  • Satisfaction with the procedure

    24 and 60 months postoperatively

  • VAS

    baseline, 24 and 60 months postoperatively

  • SST

    baseline and 24 months postoperatively

  • +6 more secondary outcomes

Study Arms (2)

double layer fixation

EXPERIMENTAL

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation

Procedure: double layer fixation

single layer fixation

EXPERIMENTAL

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation

Procedure: single layer fixation

Interventions

double layer fixationPROCEDURE
double layer fixation
single layer fixationPROCEDURE
single layer fixation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
  • tear size of at least 2.5 cm and up to 4.0 cm
  • signed informed consent

You may not qualify if:

  • axillary nerve palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent Shoulder & Sports Clinic

Vienna, Austria

Location

Related Publications (1)

  • Heuberer PR, Pauzenberger L, Gruber MS, Ostermann RC, Hexel M, Laky B, Anderl W. Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates After Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):689-696. doi: 10.1177/0363546519897033. Epub 2020 Jan 9.

    PMID: 31917608DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Werner Anderl, MD

    Austrian Research Group for Regenerative and Orthopedic Medicine

    STUDY DIRECTOR

  • Philipp R Heuberer, MD

    Austrian Research Group for Regenerative and Orthopedic Medicine

    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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2017

First Posted

December 5, 2017

Study Start

June 18, 2015

Primary Completion

February 28, 2017

Study Completion

December 1, 2022

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

AU(1)