Potential Adverse Effects - Neoligaments JewelACL Instrucciones De Uso

ligament must be implanted taut while allowing full
range of motion (ROM).
• Use of fixation devices other than those listed may
damage the JewelACL and lead to potential failure
of the device.
• Chamfer the edges of the bone tunnel exits where
possible to minimize abrasion of the JewelACL.
• Ensure bone tunnel length is adequate when
using an interference screw for tibial fixation. The
screw must be centrally placed between the two
strands of the JewelACL, which should then be
tied over the back of the screw with a reef knot.
Ensure the knot is locked before trimming any
excess JewelACL.
• When using a tissue graft and an interference
screw, ensure excess graft is trimmed from
the tibial tunnel entrance prior to knotting the
JewelACL.
• When trimming the JewelACL, cut straight
across it at right angles to its length to minimize
generation of loose fibre fragments. Carefully
remove any loose fibres from the incision wound.
• Ensure that any knots remain well buried in tissue.
• Use aseptic technique throughout the procedure.
• Take care to avoid anatomical hazards, including
soft tissue and nerve damage, when making
incisions and drilling tunnels.
• Patients should be warned not to exceed
appropriate activity levels before complete healing
has occurred.
• Preoperative prophylactic antibiotics should be
administered.

Potential Adverse Effects

• Infections, both deep and superficial.
• Patient body sensitivity and adverse reaction to
device materials.
• Laxity or reduced ROM are potential adverse
consequences of misplacing the ligament.
• Laxity may also result from inadequate fixation of
the ligament to bone.
Disposal
No specific disposal requirements other than handling
contaminated items as clinical waste.
Instructions for Use
The JewelACL can be implanted using an anteromedial
or transtibial surgical technique similar to that followed
when reconstructing the ACL with hamstring grafts.
The following instructions describe an anteromedial
approach incorporating a single hamstring tendon to
produce a partial tissue sparing graft in which the
JewelACL is fixed to the femur with an EndoButton CL
Ultra (ECLU) and to the tibia with an interference screw.
1. Establish standard anterolateral (AL), anteromedial
(AM) and accessory medial portals with the knee
flexed at 90º.
2. Create a low medial accessory portal as low as
possible but above the medial joint line while
avoiding the anterior horn of the medial meniscus.
The medial-lateral placement of this portal should
be close to the medial edge of the patellar tendon
to maximize the tunnel length for such a cortical
suspension device.
3. Harvest an appropriate hamstring tendon and
prepare according to standard procedures so that
each end is whip-stitched with sutures to a length
of approximately 35-40 mm.
4. Thread the ends of the sutures through the
eyelet of a passing pin and pass it through the
appropriate openings in the JewelACL, pulling the
tendon inside. Do not pierce the JewelACL with
the passing pin.
5. Where a shallow intercondylar notch is likely to
cause impingement the knee should be flexed
beyond 90º (typically 130º) and a femoral
notchplasty performed through the AM portal.
6. Position an appropriate zero or small offset
femoral aimer through the low medial accessory
portal at the over-the-top position on the femur.
The femoral tunnel exit in the intercondylar notch
should be as far posterior and proximal as
possible while remaining within the ACL footprint
(Figure 1). Ensure that the tunnel has an adequate
wall thickness to prevent breakthrough.
7. Drill a passing pin through the femoral aimer, into
the femur and out through the anterolateral cortex.
Avoid drilling into the peroneal nerve, or damaging
the cartilage surface of the medial femoral
condyle.
8. Remove the aimer, leaving the passing pin.
Over-drill with a 4.5 mm cannulated bone tunnel
drill until the cortex is breached, then measure the
length of the tunnel.
9. Choose the appropriate size of ECLU and
assemble with the graft following the technique
described by the manufacturers to form a
two-strand graft (Figure 2). Measure the graft
diameter to determine the required bone tunnel
size.
10. Drill the femoral socket to the appropriate depth
with a drill matched to the graft size. Ensure the
drill does not breach the lateral femoral cortex,
or fixation with the ECLU cannot be performed.
Where possible chamfer the edges of the distal
tunnel at its intercondylar exit with an ACL tunnel
rasp.
11. With the knee flexed at 90º use an appropriate
tibial guide to identify the intra-articular tibial
attachment (Figure 3). This should be located
slightly medial and slightly anterior to the centre
of attachment of the natural ACL. It should not
interfere with the anterior attachment of the medial
meniscus and should avoid damaging the articular
cartilage. Avoid placing too anteriorly as this can
lead to impingement of the ligament on the roof of
the notch at full extension. Leave the tibial footprint