NCT03797287

Brief Summary

This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

January 7, 2019

Last Update Submit

May 29, 2019

Conditions

Shoulder Pain ChronicShoulder PainRotator Cuff TearRotator Cuff Injury

Outcome Measures

Primary Outcomes (1)

  • Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score

    10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).

    Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery

Secondary Outcomes (6)

  • Change in shoulder pain as assessed by Visual Analog Pain Score

    Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery

  • Change in Range of Motion (ROM)

    Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year

  • Change in Strength Testing

    Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery

  • Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index

    Before surgery, 1 year after surgery, 2 years after surgery

  • Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)

    Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery

  • +1 more secondary outcomes

Study Arms (2)

Tensor Tunnler

EXPERIMENTAL

The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice.

Device: Tensor Tunnler

Smith and Nephew PEEK Helicoil Anchor

ACTIVE COMPARATOR

The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair).

Procedure: Anchor Rotator Cuff Repair

Interventions

Tensor TunnlerDEVICE

Create the bone tunnels during the arthroscopic rotator cuff repair procedure

Tensor Tunnler
Anchor Rotator Cuff RepairPROCEDURE

The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.

Smith and Nephew PEEK Helicoil Anchor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18-75 years old
  • Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
  • Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)

You may not qualify if:

  • Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
  • Patients undergoing revision rotator cuff tears will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Columbia, Maryland, 21044, United States

Location

MeSH Terms

Conditions

Shoulder PainRotator Cuff Injuries

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Uma Srikumaran, MD, MBA

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

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

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

February 1, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(1)