Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03739749
• Other study ID #: 01-2018-10HSFX
• Status: Withdrawn
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: October 30, 2022

Study information

• Verified date: February 2023
• Source: Hospital de Egas Moniz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Graft Complication
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Lisboa Ocidental	Lisboa

Sponsors (10)

Lead Sponsor	Collaborator
Hospital de Egas Moniz	Centro Hospitalar De São João, E.P.E., Centro Hospitalar e Universitário de Coimbra, E.P.E., Centro Hospitalar Lisboa Ocidental, CUF Santarém Hospital, General Hospital of Santo António, Hospital Cuf Descobertas, Hospital de Braga, Hospital Santa Maria Maior de Barcelos, Hospital Vila Franca de Xira

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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