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Completed

NCT Number: NCT02173483

Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial

The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.

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Key information

Conditions

Ligament; Laxity, Knee Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Rupture of Anterior Cruciate Ligament Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Sports Trauma, Tage-Hansens Gade 2b

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anterior cruciate ligament rupture

Exclusion criteria

  • current malignant disease
  • Rheumatoid arthritis
  • Other knee ligament instability
  • Obesity BMI >30
  • Morbus Bechterew

Treatment and study plan

Quadriceps graft

Procedure

Primary outcomes

  1. Patient reported outcome score - IKDC

    Time frame: 12 month

    IKDC (international Knee Documentation committee) subjective score (0-100)

Secondary outcomes

  1. Knee laxity

    Time frame: 12 month

    KT-1000 arthrometer

  2. Patient reported outcome score - KOOS

    Time frame: 12 month

    Koos (Knee injury and Osteoarthritis Outcome Score) contains 5 subscores (Pain, ADL, QOL, Symptoms, Sport & recreation). Each subscore ranges from 0-100 where higher values represent a better score.

  3. TEGNER

    Time frame: 12 month

    Patient reported outcome score (range 0-10)

  4. Anterior knee pain scale

    Time frame: 12 month

    Patient reported outcome score (range 0-100)

  5. Donor Site morbidity score

    Time frame: 12 month

    Patient reported outcome score (range 100-0)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2014
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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