Hamstrings X Patellar Tendon for ACL Reconstruction in So... | NCT02642692

Studies
Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT

NCT02642692

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Status

Completed

Last Update Posted

Aug 27, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Patellar Tendon graft
Hamstring Graft

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2020Actual

First Submitted Date

Dec 25, 2015

First Submission Date that Met QC Criteria

Dec 29, 2015

First Posted Date

Dec 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luiz Gabriel Betoni Guglielmetti, MD, Master, Phd, Faculdade de Ciências Médicas da Santa Casa de São PauloPrincipal Investigator

Lead Sponsor

Faculdade de Ciências Médicas da Santa Casa de São PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.

Detailed Description

A number of techniques for ACL reconstruction have been proposed and tested, and most surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. The functional outcome after ACL reconstruction with the patellar or semitendinosus tendon has been a recent area of interest. Soccer is the most popular sport worldwide with more than 260 million active players, and it is hard to say if patellar tendon or semitendinosus grafts have different outcomes.

The purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players. The hypothesis of this study was that hamstring autograft ACL reconstruction would provide no statistically significant differences in patient-reported outcome scores, postoperative level of sports function, and harvest-site morbidity when compared with patellar tendon autograft .The Cincinnati Knee Rating System (CKRS) was chosen as the primary outcome. As secondary outcome, reruptures.

Between march 2016 and march 2017, 60 soccer players will be operated. The investigators consider as soccer players those who play more than 4 times a week. Once included in the study, they will be randomized in two groups: "hamstring group" and "patellar tendon group".

The final clinical evaluation with two years. For both groups, the technique is the same, the fixation of the grafts with metal interference screws. Femoral tunnel will be drilled with outside-in technique. The tibial tunnel with conventional 55 degrees guide.

Both groups of patients will receive the same physical therapy protocol. Data will be evaluated with the SPSS software for Windows (version 13.0).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patellar Tendon Graft	Experimental	Kind of graft that will be used for acl reconstruction	Procedure: Patellar Tendon graft
Hamstring Graft	Experimental	Kind of graft that will be used for acl reconstruction	Procedure: Hamstring Graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patellar Tendon graft	Procedure	Acl reconstruction with patellar tendon graft	Patellar Tendon Graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cincinnati Knee Rating System	It is a subjective score	2 years

Secondary Outcomes

Measure	Description	Time Frame
rerupture		2 years
International Knee Documentantion Committee (IKDC) score		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral ACL lesion
skeletally mature patients with closed physis
no previous surgery on the affected knee (except for arthroscopic meniscectomy)
less than 1 year from injury
no associated ligament injuries (except for the medial collateral ligament grade I and II)
soccer players.

Exclusion Criteria:

morbid obesity
degenerative changes in arthroscopy or image exams
those who play soccer less than 4 times / week

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
luiz G guglielmetti, MD	Faculdade de Ciencias Medicas da Santa Casa de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo		São Paulo		01221020	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10424213	Background	Corry IS, Webb JM, Clingeleffer AJ, Pinczewski LA. Arthroscopic reconstruction of the anterior cruciate ligament. A comparison of patellar tendon autograft and four-strand hamstring tendon autograft. Am J Sports Med. 1999 Jul-Aug;27(4):444-54. doi: 10.1177/03635465990270040701.
8198189	Background	Aglietti P, Buzzi R, Zaccherotti G, De Biase P. Patellar tendon versus doubled semitendinosus and gracilis tendons for anterior cruciate ligament reconstruction. Am J Sports Med. 1994 Mar-Apr;22(2):211-7; discussion 217-8. doi: 10.1177/036354659402200210.

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries