BIO INTRAFIX PDF

Page Count: 6. T ibial Soft T issue Fasteners. In-viv o studies show. A CL reconstr uction. It also feat ures a patented screw and sheath design that enhances.

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The objective of this study is to report the clinical and functional outcomes of Hamstring graft ACL reconstruction fixed with femoral Rigid-fix and tibial Bio-intrafix devices. In a prospective study, the clinical Lysholm score and functional outcomes International Knee Documentation Committee, IKDC of 44 patients who underwent autologus hamstring graft ACL reconstruction using femoral Rigid-fix and tibial Bio-intrafix devices, were evaluated at the end of one year.

None of the patients complained of instability, joint swelling or severe pain in the postoperative period. The IKDC score improved from Lysholm scores in the preoperative and follow up period were Similarly, the mean anterior translation of tibia improved from 7. No intraoperative or postoperative complications were documented.

Hamstring graft fixation using femoral Rigid-fix and tibial Bio-intrafix devices provide secure graft fixation and allows aggressive rehabilitation. The clinical and functional outcome of this hybrid fixation technique is rewarding. In anterior cruciate ligament ACL reconstruction, hamstring tendon grafts are replacing the popular bone-patellar tendon bone grafts that have been associated with femoro-tibial joint pain, loss of extension, and patellar tendon rupture.

Currently, different fixation devices are being used in clinical settings. Several biomechanical and clinical studies have shown that femoral cross-pin and tibial Intrafix or Bio-intrafix devices provide increased strength and stiffness to the graft fixation.

All patients between 18 and 45 years of age who were operated for their ACL deficient knee between Jan and Dec with autologus hamstring graft fixed by rigid-fix device in the femoral tunnel and bio-intrafix device in the tibial tunnel were prospectively evaluated. Patients with multi-ligamentous injury, infective, inflammatory or degenerative pathologies or previous history of surgery on the affected knee were excluded from the study.

Presentation of the patients within 3 months of their injury was an inclusion criterion for the study. Institutional ethics committee permission was obtained and consent from the patients was taken prior to their recruitment in the study.

Preoperative evaluation included history, clinical examination, ligamentous laxity measurement using KT arthrometer, radiographs and magnetic resonance imaging of the knee joint.

After complete clinical and radiological evaluation, patients were arthroscopically treated with ACL reconstruction using hamstring graft. All reconstructions were carried out under regional or general anaesthesia, with the patient in a supine position. Perioperative antibiotic prophylaxis comprised 1. The knee joint was accessed through two to three standard portals anteromedial and anterolateral. Meniscal injuries are addressed with partial resection or balancing.

Hamstring tendons Gracilis and Semitendinosus were harvested via a small incision over the insertion of the Pes anserinus at the anterior medial tibia by a tendon stripper, and prepared as quadruple-stranded graft Fig. The graft diameter was measured using a graft-sizing block. The femoral guide wire was drilled with appropriate femoral jig through the anteromedial portal. The femoral tunnel was drilled up to mm depth with a reamer Fig. The sleeves of the Rigidfix frame should be at the center of the lateral femoral condyle.

Then the femoral guide wire was removed and the 3. At this point it is important to check that the pins will be placed in the center of the femoral tunnel and hence through the graft Fig. The Rigidfix guide frame was detached and removed. The graft was then pulled through and it was secured in the femoral tunnel with bio-absorbable femoral ST cross pin Depuy, Mitek, Fig. Preparation of quadrupled hamstring graft with four stranded separate on one side for tibial Bio-intrafix fixation.

Similarly the ACL footprint on the tibial attachment site was identified Fig. The graft was retrieved through the tunnel and fixed with bio-Intrafix screw after the sheath placement Depuy, Mitek, Fig. Wound was closed in layers. Graft fixation on tibial side with Bio-intrafix screw after tensioning the graft with a tensioner 30N force.

Postoperatively, the knee was stabilized for three days by a zero-degree splint. Patients were allowed partial weight bearing with walking crutches immediately after surgery.

Subjects were prescribed intense physical therapy for motion exercise, and to strengthen thigh muscles. Normally, full range of motion and weight bearing was achieved at 12 weeks of surgery. Patients were followed up in outpatient clinic at the end of one month, three months, 6 months, 9 months and 12 months. Statistical analysis was performed using SPSS software ver. The mean age of patients included in this study was There were 39 males Left side involvement was noticed in 20 patients There was no obvious meniscal pathology in majority The mean pre-op IKDC score was This score improved to Lysholm score in pre-op and post-op period was Similarly, ligamentous stability as measured by KT showed significant improvement after ACL reconstruction.

The mean anterior translation of tibia in the pre-op period was 7. A positive correlation was observed between pre-op and post-op IKDC score with correlation coefficient of 0. Similarly, preop and postop Lysholm score showed significant correlation with correlation coefficient of 0.

The correlation coefficient of preoperative and postoperative KT was 0. The mean of differences of IKDC preoperative-postoperative, Lysholm preoperative-postoperative and KT preoperative-postoperative were statistically analysed to look whether there was really any difference or not. The mean of difference of KT in preoperative and postoperative evaluation was 3. This suggests that all the patients had significant improvement after ACL reconstruction with this technique of fixation.

Again, no significant difference in outcome was noticed between patients with medial and lateral meniscus injury after ACL reconstruction. No intraoperative complications i. In the postoperative period also none of the patient presented with infection, graft failure, graft slippage, restriction of movements or knee pain. In the early postoperative period, the strength of fixation of the graft is the critical point limiting aggressive rehabilitation.

The fixation has to be strong enough to withstand sudden overload or repetitive submaximal loading and stiff enough to re-establish the stability of the knee and minimize graft-tunnel motion. In addition to sufficient strength and stiffness, the fixation of the graft should be anatomic, biocompatible, safe, and reproducible and should allow undisturbed magnetic resonance imaging MRI of the knee. The fixation technique also should not hamper in revision ACL reconstruction surgery. Nevertheless, the treatment results depend on the press-fit of the graft, bone density around the femoral tunnel, and correct placement of the cross pins through the graft tendon.

TCP provides the osteoconductive bioceramic material necessary to promote bone growth into the sheath and screw. It forms a strong bone-implant interface, bonding to bone and exhibiting osteoconductive characteristics. In addition, the screw imparts uniform pressure on the four strands of hamstring graft through the sheath without causing tendon damage. The concentric placement of the screw within the sheath ensures 0 graft-to-bone placement with improved engagement. Bio-intrafix screw with sheath design was found to be effective in providing a secure fixation to the graft in this study.

The femoral rigid-fix cross-pin and tibial bio-intrafix fixations are technically simple and reproducible. Certain technical tricks definitely helped us in avoiding intraoperative hurdles. The femoral jig should be adjusted properly so that the screws do not penetrate the articular surface. The accuracy of screw track meeting the femoral tunnel was tested with a thin k-wire and it was visualized under the scope through the joint.

The cross pins were inserted as close to the joint line as possible to provide outlet graft fixation.

Additionally, posterior wall blow-out does not seem to be a serious problem because the graft was fixed within the tunnel proximal to its intra-articular outlet. Graft stabilization with absorbable pins inserted perpendicular to the femoral tunnel provides a secure fixation when compared with other soft-tissue fixation devices.

In a comparative study between femoral Rigid-fix and femoral Bio-intrafix devices tibial side was constant with Intrafix technique for hamstring graft fixation, Choi et al. In fact, another study by Choi et al. In a randomized control trial, De wall et al. They concluded that centrally placed polyethylene screw with sheath provided equivalent clinical outcomes to that of interference screw and staples at minimum 2-year follow-up.

Wang et al. It seems that femoral rigid fix and tibial Intrafix is one of the strongest fixations in ACL reconstruction using hamstring graft. Blagojevi et al. The Mitek rigid fix pins were used for femoral tunnel where as bio-absorbable screws were used for the tibial tunnel. Lysholm score and knee clinical tests were parameters used for outcome evaluation.

Donor localization morbidity was markedly reduced and they had no complications. On the basis of the improved results in graft compression as well as stability with this technique, they recommended their applied method for the reconstruction in ACL deficient knees.

Our observation of ACL reconstruction using hamstring graft with femoral Rigid-fix and tibial Intrafix techniques were outstanding. Ligamentous laxity as measured with KT also showed significant improvement with postoperative laxity of 3.

We did not encounter any complication during the intraoperative or postoperative periods. No evidences of neurovascular injury, infection, iatrogenic fracture or graft slippage or failure were documented. An early rehabilitation could be initiated in all patients because of minimal donor site morbidity and secure graft fixation.

None of the patients complained of knee pain or instability after one year follow up. The clinical and functional outcomes of soft tissue graft ACL reconstruction using femoral Rigid-fix and tibial bio-intrafix fixation devices are gratifying. These fixation devices securely fix the graft to the tunnels till biological fixation has occurred and allows aggressive rehabilitation. National Center for Biotechnology Information , U. J Clin Orthop Trauma. Published online Jul 8.

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ACL reconstruction using femoral Rigid-fix and tibial Bio-intrafix devices

The objective of this study is to report the clinical and functional outcomes of Hamstring graft ACL reconstruction fixed with femoral Rigid-fix and tibial Bio-intrafix devices. In a prospective study, the clinical Lysholm score and functional outcomes International Knee Documentation Committee, IKDC of 44 patients who underwent autologus hamstring graft ACL reconstruction using femoral Rigid-fix and tibial Bio-intrafix devices, were evaluated at the end of one year. None of the patients complained of instability, joint swelling or severe pain in the postoperative period. The IKDC score improved from Lysholm scores in the preoperative and follow up period were

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