NCT02173483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

June 17, 2014

Last Update Submit

April 25, 2019

Conditions

Ligament; Laxity, KneeRupture of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcome score - IKDC

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

    12 month

Secondary Outcomes (5)

  • Knee laxity

    12 month

  • Patient reported outcome score - KOOS

    12 month

  • TEGNER

    12 month

  • Anterior knee pain scale

    12 month

  • Donor Site morbidity score

    12 month

Study Arms (2)

Quadriceps graft

OTHER

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

Procedure: Quadriceps graft

Hamstrings Graft

OTHER

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

Procedure: Quadriceps graft

Interventions

Quadriceps graftPROCEDURE
Hamstrings GraftQuadriceps graft

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anterior cruciate ligament rupture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Tage-Hansens Gade 2b

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 32125668DERIVED

  • 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.

    PMID: 31704697DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 25, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

DK(1)