Clinical trial NCT03739749: Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts
Official title: Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tear
Graft Complication
Keywords: Arthroscopic Superior Capsular Reconstruction
Irreparable rotator cuff tear
Allograft
Autograft
Xenograft
Lead sponsor: Hospital de Egas Moniz
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Lisboa Ocidental
name: General Hospital of Santo António
name: Centro Hospitalar De São João, E.P.E.
name: Hospital Santa Maria Maior de Barcelos
name: CUF Santarém Hospital
name: Hospital de Braga
name: Centro Hospitalar e Universitário de Coimbra, E.P.E.
name: Hospital Cuf Descobertas
name: Hospital Vila Franca de Xira
First posted: 2018-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple group assignment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Constant score
timeFrame: 2 years
Secondary outcomes:
measure: Graft integrity on the magnetic resonance imaging
timeFrame: 2 years
measure: Shoulder active range of motion
timeFrame: 2 years
measure: Simple shoulder test
timeFrame: 2 years
measure: Acromiohumeral interval
timeFrame: 2 years
measure: Shoulder strength
timeFrame: 2 years
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
Study officials:
affiliation: Centro Hospitalar de Lisboa Ocidental
name: Clara Azevedo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lippitt S, Harryman DT, Matsen F. A pratical tool for function evaluation: the
citation: Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
citation: Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
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.