Reconstruction of the Anterior Cruciate Ligament(ACL-R) in the 30+-Year Old Assessed by Patient Reported Outcome Measures(PRO) Using the Nationwide Danish Knee Ligament Reconstruction Registry

NCT04592367 | Completed

• 1 other identifier: PRO-4ACL
• Study Type: observational
• Target: 30,487
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy of primary ACL-R in patients 30 years of age or older using PRO. The PRO used are Knee Osteoarthritis Outcome Score(KOOS) and Tegner score. The Danish Knee Ligament Reconstruction Registry has data including more than 31,000 primary ACL-R performed in the period from 2005 to 2018, of which approximately a little less than 40% are performed in patients 30 years or older. Traditionally, ACL-R has been used for the active, younger patients with the purpose of returning to their pre-injury level of activity. The increasing activity level and the desire to stay active among some patients in their fourth decade, and later, possibly increases the demands of the reconstructed ACL in this group. The aim is to investigate the PRO in this group of patients and compare them with the PRO of patients younger than 30 years of age. The study may help orthopedic surgeons counselling patients 30 years of age or older when deciding to perform an ACL-R. The study's hypothesis is, that the overall benefit from ACL-R is equal but the patients 30 years of age or older has a worse baseline and as an implication of that worse PRO one year after the ACL-R.

Conditions

Cruciate Ligament Rupture

Keywords

ACL,; PRO; PROM; age

Outcome Measures

Primary Outcomes (1)

• Change in KOOS

  From before surgery, but after injury, to one year after surgery

Secondary Outcomes (3)

• Total KOOS

  One year after surgery

• Total Tegner score

  One year after surgery

• Change in Tegner score

  From before surgery, but after injury, to one year after surgery

Interventions

Patient age at time of procedure of reconstruction of ACL PROCEDURE

Primary reconstruction of ACL with no other concomitant ligament reconstructions. Treatment of cartilage og meniscal injury may be a part of the procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is the entire Danish population. The completeness of registry, the epidemiology of ACL-rupture and ACL-R decides the composition of the cohort.

You may qualify if:

• Patients receiving primary reconstruction of the ACL in the period 1st of January 2005 to 31st of December 2018

You may not qualify if:

• Multi Ligament Surgery
• Revision surgery of ACL

Sponsors & Collaborators

• Region Zealand: lead

Study Sites (1)

Department of Orthopedic Surgery

Køge, Region Zeland, 4600, Denmark

Location

Study Officials

• Jesper Glerup, Medical Student

  Region Zealand

  PRINCIPAL INVESTIGATOR

• Jakob Klit, MD, PhD, Associate Professor

  Region Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Student

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2005
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)