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

Surgery Clinical Trial

— Studie ACL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05876013
• Other study ID #: REK-Nr: #391796
• Status: Completed
• Start date: March 14, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

391796. Additionally, the project will be reported to NSD when the REK-application is approved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL
• ACL Injury
• ACL Tear
• Anterior Cruciate Ligament Injuries
• Cruciate Ligament Rupture
• Rupture
• Surgery

Intervention

Procedure:
• ACL reconstruction
Randomized between hamstring and patellar tendon graft

Locations

Country	Name	City	State
Norway	St Olav Hospital	Trondheim	Trondelag

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Haraldsplass Deaconess Hospital, Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gonarthrosis measurement	Kellgren Lawrence classification was used to determine grade of gonarthrosis in operated and non-operated knee, both in patello-femoral and tibio-femoral joint.	Examination day, 1 day
Secondary	Biodex isokinetic testing	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.	Examination day, 1 day.
Secondary	KOOS score	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.	Examination day, 1 day
Secondary	Lysholm's functional score	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.	Examination day, 1 day
Secondary	Tegner's activity score	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.	Examination day, 1 day.
Secondary	Pivot shift test	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.	Examination day, 1 day.
Secondary	Lachmann test	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.	Examination day, 1 day.