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Which patient with an anterior cruciate ligament rupture will need a surgical reconstruction?*

Which patient with an anterior cruciate ligament rupture will need a surgical reconstruction?* - ACL algorithm study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55314
Enrollment
230
Registered
2020-04-08
Start date
2020-09-15
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

anterior cruciate ligament rupture tear

Interventions

Intervention group: a treatment algorithm has been formulated, based on a previous performed systematic review, results of recently finished RCT, and an assigned ACL expert panel. Special attention

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 year or older, with a complete primary ACL rupture (confirmed by MRI and physical examination), maximum of 6 weeks of physical therapy, and willing to comply with the study protocol.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: multi ligament trauma indicated for surgical intervention, presence of another disorder that affects the activity level of the lower limb, pregnancy, and insufficient command of the Dutch language.

Design outcomes

Primary

MeasureTime frame
Recovery of physical functioning during 2 years assessed by the IKDC questionnaire. Besides, differences in medical consumption, absence from work or decreased productivity, and patient costs, will be assessed.

Secondary

MeasureTime frame
- Return to sport activity and level of sport activity: Tegner score. - Knee pain: number rating scale (NRS) - Knee specific outcome score (Knee Injury and Osteoarthritis Outcome Score (KOOS)) - Satisfaction with treatment - Kinesiophobia: Tampa scale - General quality of life: EQ-5D-5L - total costs: intramural and extramural medical costs (iMCQ) and productivity loss (iPCQ); - adverse events - physical examination, stability tests of the knee: Lachman, anterior drawer and pivot shift tests

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026