NCT03739749

Brief Summary

Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.

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 Oct 2018

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

November 9, 2018

Last Update Submit

February 27, 2023

Conditions

Rotator Cuff TearGraft Complication

Keywords

Arthroscopic Superior Capsular ReconstructionIrreparable rotator cuff tearAllograftAutograftXenograft

Outcome Measures

Primary Outcomes (1)

  • Constant score

    Constant score at 2 years postoperatively (minimum 1 point - maximum 100 points); For the scale range provided, higher values represent a better outcome

    2 years

Secondary Outcomes (5)

  • Graft integrity on the magnetic resonance imaging

    2 years

  • Shoulder active range of motion

    2 years

  • Simple shoulder test

    2 years

  • Acromiohumeral interval

    2 years

  • Shoulder strength

    2 years

Study Arms (6)

Fascia lata autograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using a fascia lata autograft

Procedure: Arthroscopic superior capsular reconstruction

Fascia lata allograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using a fascia lata allograft

Procedure: Arthroscopic superior capsular reconstruction

Achilles tendon allograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using an achilles tendon allograft

Procedure: Arthroscopic superior capsular reconstruction

Bovine pericardium allograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using a bovine pericardium allograft

Procedure: Arthroscopic superior capsular reconstruction

Swine dermal xenograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using a swine dermal xenograft

Procedure: Arthroscopic superior capsular reconstruction

Collagen allograft

ACTIVE COMPARATOR

Arthroscopic superior capsular reconstruction using a collagen allograft

Procedure: Arthroscopic superior capsular reconstruction

Interventions

Arthroscopic superior capsular reconstructionPROCEDURE

The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Achilles tendon allograftBovine pericardium allograftCollagen allograftFascia lata allograftFascia lata autograftSwine dermal xenograft

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rotator cuff tear arthropathy, Hamada stage 1 or 2
  • Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging

You may not qualify if:

  • Rotator cuff tear arthropathy, Hamada stage 3 or 4
  • Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
  • Proximal humerus fracture
  • Acute shoulder dislocation (in the previous 8 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar de Lisboa Ocidental

Lisbon, 1700-348, Portugal

Location

Related Publications (4)

  • Lippitt S, Harryman DT, Matsen F. A pratical tool for function evaluation: the

    BACKGROUND

  • Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.

    PMID: 2323151BACKGROUND

  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

    PMID: 3791738BACKGROUND

  • Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.

    PMID: 18061114BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Clara Azevedo

    Centro Hospitalar de Lisboa Ocidental

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multiple group assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

October 30, 2018

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)