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Anterior Cruciate Ligament Reconstruction: Bone-Patellar Tendon-Bone Compared with Double Semitendinosus and Gracilis Tendon GraftsA Prospective, Randomized Clinical Trial
Paolo Aglietti, MD1; Francesco Giron, MD1; Roberto Buzzi, MD1; Flavio Biddau, MD1; Francesco Sasso, MD1
1 First Orthopaedic Clinic, University of Florence, Largo Pietro Palagi 1, 50139 Florence, Italy. E-mail address for F. Giron: ortosec@unifi.it
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The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
Investigation performed at the First Orthopaedic Clinic, University of Florence, Florence, Italy

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2004 Oct 01;86(10):2143-2155
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Background: The choice of graft for anterior cruciate ligament reconstruction is a matter of debate, with patellar and hamstring tendons being the two most popular autologous graft options. The objective of this study was to determine in a prospective, randomized clinical trial whether two grafts (bone-patellar tendon-bone or doubled hamstring tendons) fixed with modern devices affect the two-year minimum clinical and radiographic outcomes of anterior cruciate ligament reconstruction.

Methods: One hundred and twenty patients with a chronic unilateral rupture of the anterior cruciate ligament underwent arthroscopically assisted reconstruction with use of either autologous bone-patellar tendon-bone or doubled hamstring tendon grafts, in a strictly alternating manner. Both groups were comparable with regard to demographic data, preoperative activity level, mechanism of injury, interval between the injury and the operation, and the amount of knee laxity present preoperatively. The same well-proven surgical technique and aggressive controlled rehabilitation was used. An independent observer, who was blinded with regard to the involved leg and the type of graft, performed the outcome assessment with use of a visual analog scale, the new International Knee Documentation Committee form, the Knee Injury and Osteoarthritis Outcome Score, the Functional Knee Score for Anterior Knee Pain, and an arthrometric and an isokinetic dynamometric evaluation. Radiographs were also made.

Results: At the two-year follow-up evaluation, no differences were found in terms of the visual analog score, the Knee Injury and Osteoarthritis Outcome Score, the new International Knee Documentation Committee subjective and objective evaluation scores, the KT-1000 side-to-side laxity measurements, the Functional Knee Score for Anterior Knee Pain, muscle strength recovery, or return to sports activities. In the bone-patellar tendon-bone group, we found a higher prevalence of postoperative kneeling discomfort (p < 0.01) and an increased area of decreased skin sensitivity (p < 0.001). In the hamstring tendon group, we recorded a higher prevalence of femoral tunnel widening (p < 0.01). In this group, a correlation was also found between medial meniscectomy and an increased prevalence of pivot-shift glide (p = 0.035).

Conclusions: We believe that, with use of accurate and proven surgical and rehabilitation techniques, both grafts are an equivalent option for anterior cruciate ligament reconstruction.

Level of Evidence: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]). See Instructions to Authors for a complete description of levels of evidence.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Francesco Giron, M.D.
    Posted on March 11, 2005
    Dr. Giron responds to Dr. Fox
    Prima Clinica Ortopedica, University of Florence, Florence, Italy

    To the Editor:

    I would like to thank Dr. Fox for her question which allows me to explain our randomization method. In our study the patients were selected in the following way:

    Each patient on a waiting list of our Clinic that is in a public hospital was called by a resident. The waiting list includes more than 1300 patients who are waiting for different types of surgeries by nine different orthopaedic surgeons. . The patient's registration number determined the graft choice: odd numbers were allotted to receive a BPTB graft while even numbers underwent hamstring reconstruction.

    The patients were investigated preoperatively by the same independent observer who evaluated them at the follow-up. (Dr. Giron);

    Each patient was informed about the study and signed an informed consent form. They were aware that the only difference in the procedure was the type of the graft employed. They did not know which graft would be used for their reconstruction but they were informed about our percentage of success with each graft based on previous studies.

    Patients who refused to take part in the study or wanted to personally choose the graft were not included in the study.

    5. The surgeon (Prof. Aglietti) performed the surgery and selected the type of graft on the basis of the patient's registration number on the waiting list. He met the patients in the OR and was not able to influence the selection. The procedures were performed alternately (odd and even numbers sequentially) up to 120.

    There are several way to allocate patients in clinical studies, but I think that this method of allocating the patients (registration number in a general waiting list including also other patients undergoing different types of surgeries) could be reasonably considered "randomized" and not "deterministic" because at the time of registration in the waiting list each patient had the same probability of receiving an odd or an even number.

    Sincerely yours,

    Francesco Giron, MD

    Anna E Fox
    Posted on February 10, 2005
    Use of the term "Randomized"
    Stepping Hill hospital, Stockport, UK

    To the Editor:

    We read with interest the excellent article by Aglietti et al [1]. However we feel that it cannot be described as a "randomized" trial. Randomization was achieved be a "strictly alternating" pattern of treatment allocation, which is open to sources of potential bias. Despite this method of allocation the two groups are very well matched, although there is no discussion in the article as to whether a stratification process was used to achieve this.

    The term 'randomized' has a precise statistical meaning in that each patient has the same probability of receiving either treatment, independent of the previous patients allocation [2]. this is clearly not the case here. In addition, the term "strictly" is difficult to interpret. Although the procedure performed at each successive operation may have alternated, we feel further information should be supplied concerning the processes of entering patients into the trial. In particular, the surgeon's role in influencing the treatment received, and whether allocation was by third party. In addition there is no information about the patients who declined entry into the study or withdrew once they knew which treatment arm they had been allocated to, again both potential sources of bias. Using alternation to allocate treatment is thus better described as 'deterministic' and the term 'randomized' should not be used.

    We note a previous study by the same author [3] used the same method of treatment allocation, however this was not described as 'randomized' but more appropriately as a "prospective comparative study". Interestingly, subsequent papers refering to this study have inadvertently described it as randomized [4,5].

    Since the CONSORT guidelines [6] were published, there has been an increased recognition of the importance of methodology, and its justification in research, and there has been a greater emphasis on the reporting of randomized controlled trials. Unfortunately, despite being an otherwise excellent study, this work has left itself open to criticisms of the allocation method used, and thus the potential for bias.

    1. Aglietti P, Giron F, Buzzi R et al. Anterior cruciate ligament reconstruction: Bone-patellar tendon-bone compared with double semitendinosus and gracilis tendon grafts. JBJS-A 2004; 86A: 2143-55.

    2. Altman D. Practical statistics for medical research-chapter 5. Chapman & Hall 1991.

    3. Aglietti P, Buzzi R, Zaccherotti G et al. Patella tenodn versus doubled semitendinosus and gracilis tendons for anterior cruciate ligament reconstruction. Am J Sports Med 1994; 22(2): 211-8.

    4. Erikson K, Anderberg P, Hamberg P et al. A comparison of quadruple semitendinosus and patella tendon grafts in reconstruction of the anterior cruciate ligament. JBJS-B; 83B: 348-54.

    5. Shaieb MD, Kan DM, Chang SK et al. A propsective randomised comparison of patella tendon versus semitendinosus and gracilis tendon autografts for anterior cruciate ligament reconstruction. Am J Sports Med 2002; 30(2): 214-21.

    6. Begg C, Cho M, Eastwood, S et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637-9.

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