Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction

NCT ID: NCT03626883

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2022-07-30

Brief Summary

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The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.

Detailed Description

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The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.

The study will recruit 60 patients per each of two arms.

Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1 hamstring

Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.

Group Type EXPERIMENTAL

single-bundle, single-hamstring ACL reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction with single hamstring tendon

2 hamstrings

Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.

Group Type ACTIVE_COMPARATOR

single-bundle, double-hamstring ACL reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction with 2 hamstring tendons

Interventions

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single-bundle, single-hamstring ACL reconstruction

anterior cruciate ligament reconstruction with single hamstring tendon

Intervention Type PROCEDURE

single-bundle, double-hamstring ACL reconstruction

anterior cruciate ligament reconstruction with 2 hamstring tendons

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear

Exclusion Criteria

* revision anterior cruciate ligament surgery
* other lower limb injuries
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rafał Kamiński

OTHER

Sponsor Role lead

Responsible Party

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Rafał Kamiński

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcin K Wasko, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Postgraduate Medical Education in Warsaw

Locations

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Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education

Otwock, Woj. Mazowieckie, Poland

Site Status

Countries

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Poland

References

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Kulinski K, Wasko MK, Trams E, Malesa K, Pomianowski S, Kaminski R. Anterior Cruciate Ligament Reconstruction Using a 4-Strand Semitendinosus Tendon Graft or a Doubled Semitendinosus and Gracilis Tendon Graft: A 4.5-Year Prospective, Randomized, Double-Blind, Parallel-Group Study. Am J Sports Med. 2023 Mar;51(3):615-626. doi: 10.1177/03635465221149738.

Reference Type DERIVED
PMID: 36856280 (View on PubMed)

Other Identifiers

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1vs2 ham

Identifier Type: -

Identifier Source: org_study_id

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