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

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173483
• Other study ID #: Danish EC - 110728514
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Anterior cruciate ligament rupture

Exclusion Criteria:

• current malignant disease

• Rheumatoid arthritis

• Other knee ligament instability

• Obesity BMI >30

• Morbus Bechterew

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Ligament; Laxity, Knee
• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• Quadriceps graft

Locations

Country	Name	City	State
Denmark	Division of Sports Trauma, Tage-Hansens Gade 2b	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcome score - IKDC	IKDC (international Knee Documentation committee) subjective score (0-100)	12 month
Secondary	Knee laxity	KT-1000 arthrometer	12 month
Secondary	Patient reported outcome score - KOOS	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.	12 month
Secondary	TEGNER	Patient reported outcome score (range 0-10)	12 month
Secondary	Anterior knee pain scale	Patient reported outcome score (range 0-100)	12 month
Secondary	Donor Site morbidity score	Patient reported outcome score (range 100-0)	12 month