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

Sponsor
St. Olavs Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05876013
Collaborator
Lovisenberg Diakonale Hospital (Other), Haraldsplass Deaconess Hospital (Other)
114
Enrollment
1
Location
6.8
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ACL reconstruction

Detailed Description

Introduction Rupture of the anterior cruciate ligament (ACL) is a common soft-tissue knee injury, and has increased in number over the last twenty years. Reconstructing the ligament may be important for maintaining the stability and preventing further damaging of the knee. The two most commonly used grafts in reconstructions are the autologous patellar tendon grafts and hamstring tendon grafts There is yet to be a universally established agreement regarding which reconstruction method of an ACL is preferred. The method using the central third of the patellar tendon with proximal and distal bone blocks as the replacement has been used since the late 80s and is well documented with good results. When the technique using the hamstring tendon grafts was introduced, its popularity increased. Arguments favoring each of the methods depend on which variables one values the most. In some studies, the patellar tendon group reported problems regarding anterior knee pain and decreased sensitivity of the knee, whereas for the hamstring tendon group there was reported increased weakness of the hamstring muscles and knee laxity. However, the overall assessment and satisfaction in multiple short-term/semi-long studies have shown little to no difference .

The aim of this prospective randomized multicenter study is to compare the use of bone-patellar tendon-bone (BPTB) grafts and double-looped semitendinosus gracilis (DLSG) grafts for reconstruction of the anterior cruciate ligament, 17-20 years after the surgery. The null hypothesis is that there will be no significant differences at this long-term follow-up evaluation between the two methods.

Method and material of the first study- Drogset et al. recruited 115 patients with rupture of the anterior cruciate ligament in the period of 2001-2004, and randomized them to either reconstruction with bone-patellar tendon-bone (BPTB) grafts fixed with metal interference screw graft, or double-looped semitendinosus gracilis (DLSG) grafts fixed with Bone Mulch Screws and WasherLoc Screws. The surgeries were performed at four different hospitals.

After one and two years, the patients were examined by an independent observer, using a series of objective tests, as well as recording the patients' subjective opinion of their knee function. The subjective tests used were Tegner's activity score, Lysholm's functional score and Modified Cincinnati Score. The objective tests used were Lachmann's test, pivot shift and KT-1000, as well as Cybex and Biodex to measure muscle strength.

Method and material- The present study is a long-term follow-up of a prospective randomized multicenter study. The patient recorded outcome scores will be Tegner's activity score, Lysholms's functional score and the Knee injury Osteoarthritis Outcome Score (KOOS). The examinations include Lachmann's test, pivot shift and KT-1000. We also plan to include radiographs to evaluate the degree of arthrosis 17-20 years after the surgery, and Cybex or Biodex to examine the hamstring and quadriceps strength. The radiographic positioning will be knee AP weight-bearing standing bilateral and lateral view, as well as skyline projection. The Kellgren-Lawrence classification will be used to assess the degree of osteoarthritis.

Even though 115 patients were included in the original study, we will only attempt to contact 114 due to lost inclusion-papers between the 2-year and 7-year follow-up [8]. During the spring of 2022, the patients will receive an invite to participate in the follow-up study. Following this, patients will be contacted to uncover different circumstances that might exclude certain patients from the clinical assessment. This includes revision of the reconstruction in question, total knee replacement or total knee arthroplasty, and if the knee had been injured beforehand. The clinical examination will be carried out by both a medical student and an experienced orthopedic surgeon. Hopefully all the patients will be examined over the course of two days at each location, and if needed, the rest will be examined at a later date.

Hypothesis- Current hypothesis is that there will be no difference in the long-term outcome between the two groups. However, it will be interesting to see how many patients have received a prosthesis, and how many patients struggle with arthrosis. As the previous follow-up studies showed a significant difference in total flexion work between the two groups, we will be interested in detecting a persistent difference between the groups.

Another interesting aspect will be the rate of graft failure between the two groups.

Feasibility- The strength of the study is the randomization and the long follow-up period of 17-20 years. The possible limitations are the fact that there may be a problem recruiting enough patients to the follow-up, and that it might not be able to get x-rays of the patients at the different hospitals, as this is a matter of cost and availability. In addition, the different hospitals may not have a Biodex available.

Publicity plan- The goal for the paper is to be published in an international journal and probably be presented at conferences. For article, that hopefully will be published in journals, Marko Popovic will stand as first author, and Julie Holen and Julie Myhre as contributing authors. Jon Olav Drogset will be listed last, as the main supervisor.

Ethics- The REK-application was submitted on the 24th of December 2021. Application number:
  1. Additionally, the project will be reported to NSD when the REK-application is approved.

Study Design

Study Type:
Observational
Actual Enrollment :
114 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group
Actual Study Start Date :
Mar 14, 2022
Actual Primary Completion Date :
Oct 7, 2022
Actual Study Completion Date :
Oct 7, 2022

Arms and Interventions

Arm Intervention/Treatment
BPTB group

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

Procedure: ACL reconstruction
Randomized between hamstring and patellar tendon graft
Other Names:
  • Graft choice,

    		•
    Hamstring group

    Double-looped semitendinosus and gracilis graft used for ACL reconstruction

    Procedure: ACL reconstruction
    Randomized between hamstring and patellar tendon graft
    Other Names:
  • Graft choice,

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lachmann test [Examination day, 1 day.]

      Lachmann test- Anterior translation of the tibia associated with a soft or a mushy end-feel indicates a positive test. More than about 2mm of anterior translation compared to the uninvolved knee suggests a torn ACL ("soft end-feel"), as does 10mm of total anterior translation.

    2. Pivot shift test [Examination day, 1 day.]

      Pivot shift test- positive test is indicated by subluxation of the tibia while the femur rotates externally followed by a reduction of the tibia at 30-40 degrees of flexion.

    3. KT-1000 arthrometer [Examination day, 1 day.]

      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.

    Secondary Outcome Measures

    1. Gonarthrosis measurement [Examination day, 1 day]

      Kellgren Lawrence classification was used to determine grade of gonarthrosis in operated and non-operated knee, both in patello-femoral and tibio-femoral joint.

    2. Biodex isokinetic testing [Examination day, 1 day.]

      Biodex is a isokinetic machine used to measure muscle strength and identify weaknesses in certain muscle groups. It can be used in different degrees to measure muscle strength in different positions of the joint.

    3. KOOS score [Examination day, 1 day]

      The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems, is common in orthopaedic instruments and generic measures like the SF-36.

    4. Lysholm's functional score [Examination day, 1 day]

      In the modified Lysholm system the maximum score is 100 points, in which: 91 to 100 points is considered excellent; 84 to 90, good; 65 to 83, fair; and 64 or less, unsatisfactory. Lysholm's system is an evaluation system that includes three functional criteria and five subjective criteria.

    5. Tegner's activity score [Examination day, 1 day.]

      The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    ->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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Olav Hospital Trondheim Trondelag Norway 7030

    Sponsors and Collaborators

    • St. Olavs Hospital
    • Lovisenberg Diakonale Hospital
    • Haraldsplass Deaconess Hospital

    Investigators

    • Study Chair: Jon O. Drogset, PhD, St Olav Hospital Trondheim

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    St. Olavs Hospital
    ClinicalTrials.gov Identifier:
    NCT05876013
    Other Study ID Numbers:
    • REK-Nr: #391796
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rupture
    Anterior Cruciate Ligament Injuries

    Study Results

    No Results Posted as of May 25, 2023