Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group Compared to Patellar Tendon Group

NCT05876013 | Completed DMC

• 1 other identifier: 391796
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL; ACL Injury; Cruciate Ligament Rupture; ACL Tear; Surgery

Outcome Measures

Primary Outcomes (1)

• KT-1000 arthrometer

  KT-1000 test- The KT1000 arthrometer was designed to measure the anterior translation of the tibia while maintaing the femur in position. The results obtained provide an objective diagnostic of the state of the ACL to the medical practitioner.

  Examination day, 1 day.

Secondary Outcomes (7)

• Gonarthrosis measurement

  Examination day, 1 day

• Biodex isokinetic testing

  Examination day, 1 day.

• KOOS score

  Examination day, 1 day

• Lysholm's functional score

  Examination day, 1 day

• Tegner's activity score

  Examination day, 1 day.

Study Arms (2)

BPTB group

Bone-patellar tendon- bone graft used for ACL reconstruction.

Procedure: ACL reconstruction

Hamstring group

Double-looped semitendinosus and gracilis graft used for ACL reconstruction

Procedure: ACL reconstruction

Interventions

ACL reconstruction PROCEDURE

Randomized between hamstring and patellar tendon graft

Also known as: Graft choice,

BPTB group; Hamstring group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Norwegian citizens. Patients from Trondelag county operated in Trondheim (StOlav Hospital), patients from Oslo operated at Lovisenberg Diaconal Hospital Oslo, patients from Hordaland operated at Haraldsplass Deaconess Hospital Bergen. Few patients from other counties who wanted operation at spesific hospital were also included if inclusion criteria were met.

You may qualify if:

• Primary reconstructions of isolated ACL-ruptures. Surgery at least 6 weeks after injury. Age 18-45 years.
• The patient must understand and accept the written consent. The written consent must be signed by the patient before surgery.
• Normal two-plane X-ray of the knee.

You may not qualify if:

• \>5mm + chronic MCL-injury in the same knee.
• Patient with major additional injury in the knee: combined instability, cartilage injuries Outerbridge grade 3-4 and at least 1cm in diameter on the femoral condyle and major meniscal lesions with meniscal repairs.
• Patients having problems following the protocol.
• The patient does not understand the written consent or will not sign it.
• Patients with a history of alcohol or drug abuse the last three years.
• The patient has received any investigational drugs within 30 days prior to admittance to this study.
• The patient has O.A., podagra, RA, Bechterew's disease or chondrocalcinosis.
• The patient has malalignment with more than 5 degrees valgus and no varus compared to a normal knee.
• The patient has patellofemoral instability.
• The patient is obese with BMI\>30.
• The patient has a present or former serious illness that makes follow-up or rehabilitation of the patient difficult.
• Former major surgical procedures in the same knee, including prosthesis.
• Treated or untreated anterior cruciate ligament injury in the other knee.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Lovisenberg Diakonale Hospital: collaborator
• Haraldsplass Deaconess Hospital: collaborator

Study Sites (1)

St Olav Hospital

Trondheim, Trøndelag, 7030, Norway

Location

Related Publications (31)

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  PMID: 39221503 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jon O. Drogset, PhD

  St Olav Hospital Trondheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 25, 2023
• Study Start: March 14, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)