Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT05747079

Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28

280

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

B

Belgian Health Care Knowledge Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Currently, most patients with an anterior cruciate ligament injury undergo surgery. There is a general belief that surgical reconstruction is necessary to safely return to sports and to prevent early knee osteoarthritis or additional meniscus injuries. But there is insufficient scientific evidence to support this belief. Moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of osteoarthritis and secondary meniscus injuries. Therefore, immediate surgery after an anterior cruciate ligament injury is questioned. So far, only two RCTs (KANON study and COMPARE study) have assessed this, and they could not show that immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or additional meniscal injuries) compared to a conservative approach consisting of rehabilitation and late surgery for persistent knee instability. Therefore, this additional multicenter RCT, aims to 1) verify these results and 2) to identify predictors that predict which patients in the conservative group will not require late surgery. This has not been investigated to date. It is suspected that factors such as symptoms, strength, findings on the MRI scan and psychological factors may play a role in whether or not a patient will be able to successfully rehabilitate without surgical repair. This information is invaluable to physicians because it allows them to decide which treatment is best for the patient.

CONDITIONS

Official Title

Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Rotational trauma to a knee with no previous serious injury and medical advice sought within 4 weeks after the injury
  • Medical diagnosis of ACL insufficiency confirmed by MRI, including partial or complete ruptures
  • At least 16 years old
Not Eligible

You will not qualify if you...

  • History of previous ACL injury or knee surgery on the affected knee
  • Need for acute surgery due to related knee injuries
  • Female who is pregnant or plans pregnancy within the first 4 months of the trial due to MRI restrictions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

A

Annemie Smeets, phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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