MRI assessment and patient specific biomechanical modelling of ACL deficient knees to improve ACL reconstructive surgery; a feasibility study.

MRI assessment and patient specific biomechanical modelling of ACL deficient knees to improve ACL reconstructive surgery; a feasibility study. - MRI based modelling of ACL reconstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42444

Enrollment

Registered

2015-06-01

Start date

2015-07-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Rupture Torn ligament

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The subject should be 18 years old or older. The subject should have an ACL rupture in one knee. The subject should have a non-ACL deficient knee. The subject should be able to read and understand the subject information. The subject should be planned for a hamstrings tendon revision.

Exclusion criteria

Exclusion criteria: The subject has a joint replacement implant. The subject has lower limb arterial insufficiency. The subject has venous diseases. The subject has haemophilia. The subject has known or suspected osteoporosis. The subject has a bone disease with bone fragility. The subject cannot articulate pain or discomfort. The subject does not meet standard criteria for MRI scanning.

Design outcomes

Primary

Measure	Time frame
The main parameters (antero-posterior and rotational laxity) will be statistically analyzed using a t-test or a paired t-test. The difference in rotation due to the attachment sides will be analyzed using Spearmen correlation. Additionally, regression analysis is used to determine the reliability of the clinical tests compared to the PKTD. Because, this is a feasibility study all p-values generated in hypothesis testing will be interpreted within the context of an explorative study.	—

Measure

Time frame

The main parameters (antero-posterior and rotational laxity) will be statistically analyzed using a t-test or a paired t-test. The difference in rotation due to the attachment sides will be analyzed using Spearmen correlation. Additionally, regression analysis is used to determine the reliability of the clinical tests compared to the PKTD. Because, this is a feasibility study all p-values generated in hypothesis testing will be interpreted within the context of an explorative study.

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Secondary

Measure	Time frame
n.v.t	—

Countries

Netherlands

Outcome results