Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis

NCT03663036 | Completed DMC

• 1 other identifier: 01-2018-07HSFX
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

An irreparable rotator cuff tear (IRCT) is a challenge, with a controversial definition and different treatment options. None of the latter are exempt of limitations and their survivorship is one of the concerns. In 2013, Mihata et al. proposed a novel treatment option: arthroscopic superior capsular reconstruction using a fascia lata autograft (FL-ASCR) harvested through an open approach. Although no harvest site dysfunction was reported, concerns about donor site morbidity discouraged the use of this type of graft. In 2015, the investigators modified the original FL-ASCR introducing a minimally invasive fascia lata harvesting technique, aiming to reproduce FL-ASCR's promising clinical results in IRCT, while reducing donor site morbidity. The investigators aim to: 1) Evaluate the mid-term outcomes and donor site morbidity impact of FL-ASCR with minimally invasive harvesting; 2) Analyze the mid-term graft integrity to determine its survivorship 3) Establish clinical and imaging graft integrity correlations to guide the future treatment algorithm.

Conditions

Graft Failure; Donor Site Complication; Rotator Cuff Tear

Keywords

Arthroscopic Superior Capsular Reconstruction; Fascia Lata; Autograft; Donor Site Morbidity; Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Shoulder outcomes of FL-ASCR with minimally invasive harvesting at 3 years postoperative

  Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; 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.). Bilateral functional shoulder scores: the simple shoulder test (SST, 1-12 points), the subjective shoulder value (SSV, 0-100%) and the constant score (CS, 1-100 points). Bilateral shoulder strength (supraspinatus, infraspinatus, subscapularis and teres minor, 0 -15 kg). For every scale range provided, higher values represent a better outcome.

  2 years

Secondary Outcomes (2)

• Autograft mid-term survivorship at 3 years postoperative

  2 years

• Fascia lata minimally invasive harvesting donor site morbidity impact at 3 years postoperative

  2 years

Study Arms (1)

FL-ASCR

EXPERIMENTAL

Magnetic Resonance Imaging of the shoulder Radiograph of the shoulder

Diagnostic Test: Magnetic Resonance Imaging of the shoulder

Interventions

Magnetic Resonance Imaging of the shoulder DIAGNOSTIC_TEST

Clinical and radiological assessments of the shoulders and the donor sites

Also known as: Shoulder radiograph, Range of motion and strength measurements

FL-ASCR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• FL-ASCR by the same surgeon (principal investigator) since 2015
• completed the preoperative and the 6 months postoperative clinical, radiological and MRI assessments

You may not qualify if:

• secondary surgery for the removal of the implanted autograft in the shoulder which had previously ungergone the FL-ASCR procedure
• secondary surgery to the harvested thigh

Sponsors & Collaborators

• Clara Isabel de Campos Azevedo: lead
• Centro Hospitalar Lisboa Ocidental: collaborator

Study Sites (1)

Centro Hospitalar de Lisboa Ocidental

Lisbon, 1700-348, Portugal

Location

Related Publications (3)

• de Campos Azevedo CI, Angelo ACLPG, Vinga S. Arthroscopic Superior Capsular Reconstruction With a Minimally Invasive Harvested Fascia Lata Autograft Produces Good Clinical Results. Orthop J Sports Med. 2018 Nov 27;6(11):2325967118808242. doi: 10.1177/2325967118808242. eCollection 2018 Nov.

  PMID: 30505873 BACKGROUND

• Angelo ACLPG, de Campos Azevedo CI. Minimally invasive fascia lata harvesting in ASCR does not produce significant donor site morbidity. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):245-250. doi: 10.1007/s00167-018-5085-1. Epub 2018 Aug 1.

  PMID: 30069653 BACKGROUND

• Azevedo CIC, Catarina Leiria Pires Gago Angelo A, Campos-Correia D, Delgado L, Ferreira N, Sevivas N. Clinical Importance of Graft Integrity in Arthroscopic Superior Capsular Reconstruction Using a Minimally Invasively Harvested Midthigh Fascia Lata Autograft: 3-Year Clinical and Magnetic Resonance Imaging Outcomes. Am J Sports Med. 2020 Jul;48(9):2115-2128. doi: 10.1177/0363546520928649.

  PMID: 32667265 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Clara IC Azevedo, MD

  Centro Hospitalar de Lisboa Ocidental

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shoulder Surgery Unit Coordinator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: September 5, 2018
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)