NCT03800225

Brief Summary

The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 3, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

January 9, 2019

Last Update Submit

September 30, 2019

Conditions

Ligament; Laxity, KneeAnterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (1)

  • Knee Laxity

    KT-1000 arthrometer

    12 Months

Secondary Outcomes (3)

  • Patient reported outcome scores

    12 Months

  • Patient reported outcome scores

    12 Months

  • Pain measurement

    12 Months

Study Arms (2)

Repair

EXPERIMENTAL

Anterior cruciate ligament repair with internal brace after anterior ligament rupture.

Procedure: Repair

Patella tendon graft

ACTIVE COMPARATOR

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

Procedure: Repair

Interventions

RepairPROCEDURE

Anterior ligament repair with internal brace.

Patella tendon graftRepair

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, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

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

January 9, 2019

First Posted

January 11, 2019

Study Start

January 3, 2019

Primary Completion

September 4, 2019

Study Completion

September 4, 2019

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations

DK(1)