Phase None Completed NCT05876013

Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group

St. Olavs Hospital · Observational

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Completed October 2022. Read the results summary below →
Study context Single-site study

Overview

Background: Bone-patellar tendon-bone (BPTB) and a double-looped semitendinosus gracilis (hamstring group) graft are commonly used for ACL reconstruction. Short-term and mid-term studies show little to no significant difference between the two groups, and there are a few long term studies to compare results between the two grafts. Purpose: To compare the results after using either BPTB grafts or hamstring grafts 18 years after ACL reconstruction. Study design: Randomized controlled trial; Level of evidence II. Methods: 114 patients with ACL rupture between 2001 and 2004 were randomized to reconstruction with either BPTB graft or a hamstring graft. Patients were operated at four major hospitals. The 18-year follow-up evaluation included isokinetic testing of muscle strength, patient-reported outcome measures, clinical knee examination and an assessment of radiological osteoarthritis using the Kellgren-Lawrence classification. Hypothesis:Hypothesis is that there will be no difference in the long-term outcome between the two groups, as well hypothesis of no difference in patients with prosthesis after ACL reconstruction, arthrosis difference in operated knees and the rate of graft failure between the two groups. Previous follow-up studies showed a significant difference in total flexion work between the two groups, so detecting a persistent difference between the groups will be point of interest.

Full record on ClinicalTrials.gov (NCT ID NCT05876013).

Results summary

None

Outcome data

EndpointTypeResultSignificance
KT-1000 arthrometer Primary None None
Gonarthrosis measurement Secondary None None
Biodex isokinetic testing Secondary None None
KOOS score Secondary None None
Lysholm's functional score Secondary None None
Tegner's activity score Secondary None None
Pivot shift test Secondary None None
Lachmann test Secondary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase None
Study type
Observational
Enrollment (final)
114 participants
Started
March 2022
Actually completed
October 2022

Recruitment criteria

Age range: 18–45 · Sex: All · Healthy volunteers: Requires diagnosis

Locationsi

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

St Olav Hospital — Trondheim, Trøndelag (Norway)

Sources

REG
ClinicalTrials.gov — NCT05876013
Trial registry · primary record
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