Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts

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.

Study Overview

• Status: Withdrawn
• Conditions: Rotator Cuff Tear; Graft Complication
• Intervention / Treatment: Procedure: Arthroscopic superior capsular reconstruction

Detailed Description

Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft.

All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P<0.05.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1700-348
    • Centro Hospitalar de Lisboa Ocidental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fascia lata autograft; Arthroscopic superior capsular reconstruction using a fascia lata autograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Active Comparator: Fascia lata allograft; Arthroscopic superior capsular reconstruction using a fascia lata allograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Active Comparator: Achilles tendon allograft; Arthroscopic superior capsular reconstruction using an achilles tendon allograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Active Comparator: Bovine pericardium allograft; Arthroscopic superior capsular reconstruction using a bovine pericardium allograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Active Comparator: Swine dermal xenograft; Arthroscopic superior capsular reconstruction using a swine dermal xenograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Active Comparator: Collagen allograft; Arthroscopic superior capsular reconstruction using a collagen allograft	Procedure: Arthroscopic superior capsular reconstruction; The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft integrity on the magnetic resonance imaging	Graft integrity on the 2-year postoperative magnetic resonance imaging (scale: 0 -1): 0 = graft absent or not healed to the greater tuberosity/superior glenoid; 1 = graft present and healed to the greater tuberosity and superior glenoid. For the scale range provided, higher values represent a better outcome.	2 years
Shoulder active range of motion	Shoulder active range of motion (ROM) at 2 years postoperatively measured in degrees using an analogic goniometer: elevation (0 - 180º), abduction (0 - 180º) and external rotation (0 - 100º); and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1 - 5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5. For the scale range provided, higher values represent a better outcome.	2 years
Simple shoulder test	Simple shoulder test ((minimum 1 point - maximum 12 points) at 2 years postoperatively. For the scale range provided, higher values represent a better outcome.	2 years
Acromiohumeral interval	True anteroposterior shoulder radiograph at 2 years postoperatively: the acromiohumeral interval (AHI), considering the distance between the top of the humeral head and the undersurface of the acromion, measured using a software measurement tool (PACS, Agfa HealthCare); the RCT arthritis will be graded according to the Hamada revised radiographic classification. For the scale range provided, higher values represent a better outcome.	2 years
Shoulder strength	Shoulder strength at 2 years postoperatively measured in kilograms using a digital dynamometer: supraspinatus (0 - 25 kg).For the scale range provided, higher values represent a better outcome.	2 years

Collaborators and Investigators

• Sponsor: Hospital de Egas Moniz
• Collaborators: Hospital de Braga; Centro Hospitalar Lisboa Ocidental; Centro Hospitalar De São João, E.P.E.; Centro Hospitalar e Universitário de Coimbra, E.P.E.; General Hospital of Santo António; Hospital Santa Maria Maior de Barcelos; CUF Santarém Hospital; Hospital Cuf Descobertas; Hospital Vila Franca de Xira
• Investigators: Principal Investigator: Clara Azevedo, Centro Hospitalar de Lisboa Ocidental

Publications and helpful links

General Publications

• Lippitt S, Harryman DT, Matsen F. A pratical tool for function evaluation: the
• Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Allograft; Autograft; Xenograft; Arthroscopic Superior Capsular Reconstruction; Irreparable rotator cuff tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 01-2018-10HSFX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No