NCT02976285

Brief Summary

The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

November 15, 2016

Last Update Submit

November 23, 2016

Conditions

Rotator Cuff Tear

Keywords

arthroscopic rotator cuff repairpatch augmentation

Outcome Measures

Primary Outcomes (2)

  • Function assessed with the Constant-Murley-Score

    25 months

  • Function assessed with the Subjective Shoulder Value

    25 months

Secondary Outcomes (1)

  • Tendon integrity evaluated radiologically

    1-35 months

Interventions

arthroscopic rotator cuff repair with a polyester patchPROCEDURE

Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the time of surgery was 65 years (range 41 - 75).

You may not qualify if:

  • We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 29, 2016

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share