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Rotator Cuff TearNCT03362320

Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

A study testing double layer fixation and single layer fixation in people with Rotator Cuff Tear, run by Austrian Research Group for Regenerative and Orthopedic Medicine at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Rotator Cuff Tear
What is being tested?
double layer fixation and single layer fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteAustria
Study dates
18 Jun 2015to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • axillary nerve palsy

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • St. Vincent Shoulder & Sports Clinic

    Vienna

Other trials in Austria

About this study

Official title: A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome

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.

Being tested
double layer fixation, single layer fixation
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • double layer fixationProcedure or surgery

  • single layer fixationProcedure or surgery

Study groups in NCT03362320
Study groupRoleWhat they receive
double layer fixationExperimentalPatients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation
Receives: Procedure: double layer fixation
single layer fixationExperimentalPatients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation
Receives: Procedure: single layer fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retear rate

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

    Measured: 12 months postoperatively

Secondary outcomes (11)

  1. Constant-Murley score

    Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups

    Measured: baseline, 24 and 60 months postoperatively

  2. Range of motion (ROM)

    Comparison of ROMs between groups

    Measured: baseline, 24 and 60 months postoperatively

  3. Satisfaction with the procedure

    Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied').

    Measured: 24 and 60 months postoperatively

  4. VAS

    Comparison of the Visual Analogue Scale (VAS) between groups

    Measured: baseline, 24 and 60 months postoperatively

  5. SST

    Comparison of the Simple Shoulder Test (SST) between groups

    Measured: baseline and 24 months postoperatively

  6. ASES

    Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome.

    Measured: baseline, 24 and 60 months postoperatively

  7. qDASH

    Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups

    Measured: baseline, 24 and 60 months postoperatively

  8. WORC

    Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups

    Measured: baseline and 24 months postoperatively

  9. SSV

    Comparison of the Simple Soulder Value (SSV) between groups

    Measured: baseline, 24 and 60 months postoperatively

  10. SF-36

    Comparison of the quality-of-life score short form 36 (SF-36) between groups

    Measured: baseline, 24 and 60 months postoperatively

  11. Tendon integrity

    Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups

    Measured: baseline and 60 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start18 Jun 2015
  3. Primary completion28 Feb 2017
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362320
Sponsor's protocol ID
SLvsDL
Status last verified
Jul 2020
First submitted
16 Nov 2017
Last updated
14 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31917608

Questions about this trial

What is this clinical trial studying?

A study testing double layer fixation and single layer fixation in people with Rotator Cuff Tear, run by Austrian Research Group for Regenerative and Orthopedic Medicine at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retear rate (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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