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

Primary Purpose

Ligament; Laxity, Knee, Rupture of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Quadriceps graft
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ligament; Laxity, Knee

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anterior cruciate ligament rupture

Exclusion Criteria:

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

Sites / Locations

  • Division of Sports Trauma, Tage-Hansens Gade 2b

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Quadriceps graft

Hamstrings Graft

Arm Description

Proximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture.

The Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knee laxity
KT-1000 arthrometer
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.
TEGNER
Patient reported outcome score (range 0-10)
Anterior knee pain scale
Patient reported outcome score (range 0-100)
Donor Site morbidity score
Patient reported outcome score (range 100-0)

Full Information

First Posted
June 17, 2014
Last Updated
April 25, 2019
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02173483
Brief Title
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial
Official Title
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament; Laxity, Knee, Rupture of Anterior Cruciate Ligament

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadriceps graft
Arm Type
Other
Arm Description
Proximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture.
Arm Title
Hamstrings Graft
Arm Type
Other
Arm Description
The Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture.
Intervention Type
Procedure
Intervention Name(s)
Quadriceps graft
Primary Outcome Measure Information:
Title
Patient reported outcome score - IKDC
Description
IKDC (international Knee Documentation committee) subjective score (0-100)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Knee laxity
Description
KT-1000 arthrometer
Time Frame
12 month
Title
Patient reported outcome score - KOOS
Description
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.
Time Frame
12 month
Title
TEGNER
Description
Patient reported outcome score (range 0-10)
Time Frame
12 month
Title
Anterior knee pain scale
Description
Patient reported outcome score (range 0-100)
Time Frame
12 month
Title
Donor Site morbidity score
Description
Patient reported outcome score (range 100-0)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anterior cruciate ligament rupture Exclusion Criteria: current malignant disease Rheumatoid arthritis Other knee ligament instability Obesity BMI >30 Morbus Bechterew
Facility Information:
Facility Name
Division of Sports Trauma, Tage-Hansens Gade 2b
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32125668
Citation
Sinding KS, Nielsen TG, Hvid LG, Lind M, Dalgas U. Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Sports Med. 2020 Jul;50(7):1393-1403. doi: 10.1007/s40279-020-01276-x.
Results Reference
derived
PubMed Identifier
31704697
Citation
Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8.
Results Reference
derived

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

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