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Trilogy Longevity Constrained Liner

Stability without compromise

Trilogy® Longevity®

Constrained Liner

Surgical Technique

�Trilogy Longevity Constrained Liner

Trilogy Longevity Constrained LinerSurgical Technique

Table of Contents

Data Sheet 2

Liner Ring Removal 4

Shell Assessment 4

Locking Ring Replacement 5

Supplemental Screw Fixation 5

Liner Positioning 6

Trial Reduction and Range of Motion 7

Liner Insertion 8

Implant Assembly 10

Preparation of Constraining Ring 10 Femoral Head Reduction 10 Constraining Ring Assembly to Insert 11

Implant Disassembly (If Required) 12

Postoperative Care 13

Indications 13 Contraindications 13 Warnings 13 Precautions 13 Adverse Affects 13 Patient Counseling 13

Ordering Information 14

References 16

� Trilogy Longevity Constrained Liner

The Problem

Dislocation is the second most common major complication in THA, occurring after 0.4 - 7% of primary THAs and up to 19% of revision THAs.1-4 Dislocation can be physically destructive, leading to abductor tissue damage. Reoperation results in stability in only 69% of cases.5

Constrained inserts are designed to reduce the incidence of dislocation. However, the design of traditional constrained inserts severely restricts ROM, leading to impingement. This may lead to component failure,6,7 dislocation,4,8 and implant loosening.6

Cut-Outs Increase Range of Motion Where it is Needed Most

In a study of 111 retrieved acetabular components, researchers identified two primary sites of impingement damage.9 One site occurred where the neck impinged during full flexion or flexion plus internal rotation A (anterior-superior). The second site occurred where the neck impinged during external rotation in extension B (posterior-inferior).

Based on these findings, the Trilogy Longevity Constrained Liner was designed with cut-outs that can be placed where impingement is most likely to occur. For a left hip, the superior finger is placed at 1 o’clock, and for the right hip, it is placed at 11 o’clock to minimize the potential for impingement and optimize ROM.

Range of Motion Increase over Zimmer Trilogy Constrained insert 10

Manufactured from Longevity Highly Crosslinked Polyethylene – providing an 89% reduction in wear compared with standard polyethylene 10

Head diameters up to 36mm

Compatible with Trilogy and Trabecular Metal™ Modular Acetabular systems

Retaining fingers capture the head.

Cut-outs increase ROM.

The Solution

Trilogy Longevity Constrained Liner

A

* Data on File at Zimmer


Functionality Maintained – Constraining Mechanism

In lever-out testing, the Trilogy Longevity Constrained Liner performed as well as some of the industry’s most commonly used constrained liners. 10

Optimized Materials, Optimized Results

Longevity Highly Crosslinked Polyethylene was developed to address the issue of wear in total hip arthroplasty. Longevity Highly Cross-linked Polyethylene is produced using high-dose electron-beam radiation and an annealing process – fully crosslinking broken molecular chains so that virtually no free radicals are left. This crosslinking process produces a 10-fold wear rate reduction – an average 89 percent reduction of debris generated – when compared to standard polyethylene control samples.10 † This process leaves virtually no free radicals to promote oxidation, and creates a three- dimensional structure that is more resistant to abrasion.11,12

These acetabular systems build on the success of the Harris/Galante Porous Acetabular Component and HGP II Acetabular Shell. The Trilogy and Trabecular Metal Modular shells feature full liner-to-shell congruency and innovative liner locking mechanisms to help reduce micromotion and wear.

† Wear reduction of 90 and 88 percent for 22mm and 32mm femoral heads, respectively, when compared to standard Zimmer polyethylene. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.

They also provide two porous ingrowth options – fiber metal mesh and Trabecular Metal material – with clinically proven fixation potential.13,14

Trilogy and Trabecular Metal Modular Acetabular Systems

Trilogy Shell Trabecular Metal Modular Shell

* Data on File at Zimmer


Liner Removal

Remove the existing polyethylene liner, taking care not to damage the Trilogy/Trabecular Metal Modular shell or locking ring. Use the Disassembly Device to open the ring while at the same time using the Liner Extractor to grip and lift the liner out of the shell (Fig. 1).

Shell Assessment

Assess the shell locking ring. The ring should float freely inside the shell with the two tabs protruding through the locking ring window (Fig. 2). The ring serves to lock the liner in place. If it is damaged in such a way that it does not float freely inside the shell, remove the ring and put a new one in place.

Fig. 1

Fig. 2


Fig. 3

Fig. 4

Fig. 5

Locking Ring Replacement (If Required)

To remove the old ring, push the ring to the side of the shell and grab the exposed portion on the opposite side of the shell (Fig. 3). A firm and steady grip is required. To insert a new ring, first insert the tabs of the ring into the locking ring window (Fig. 4). Then, press the ring into place. When properly seated, the ring will first pop into place and then float freely in the shell.

Supplemental Screw Fixation

In both primary and revision cases, screw fixation is highly recommended, as the use of any constrained insert may lead to higher forces at the shell-to-bone interface. Remove any membranes from inside the shell or screw holes. Clean and inspect the shell to ensure its integrity and stability. If supplemental fixation is desired for the Trilogy or Trabecular Metal Modular Cluster-Holed or Multi-Holed Shells, insert 4.5mm or 6.5mm Trilogy Bone Screws before performing a trial reduction (Fig. 5).

Warning: Avoid placing screws in the anterior superior or anterior inferior quadrants to protect against neurologic and vascular injury.


Liner Positioning

Select the liner provisional that matches the implanted shell and place it in the shell. Check to be certain that all soft tissue has been cleared from the shell periphery. To achieve complete congruency, dry inner shell thoroughly (Fig. 6a & 6b). The anti-rotational slots on the provisional liner should line up with the two anti-rotational tabs and black etch marks located on the rim of the shell (Fig. 7a & 7b). The aim of the trial reduction is to locate the optimal rotational position of the constraining fingers to maximize range of motion. This position may vary from patient to patient because of variations in anatomy and shell placement. For the initial trial range of motion, one of the constraining fingers of the appropriate-sized trial insert is placed at approximately 1:00 for a left hip or 11:00 for a right hip (Fig. 8). The trial inserts can be used with a captured screw that is threaded into the dome of the acetabular shell with a straight hex-head screw driver.

Warning: The captured screw is intended only to temporarily hold the trial insert in place and should not be overly tightened. Two-finger tightening is sufficient. Breakage can occur with excess torque on the captured screw.

Anti-rotational tab and slot misaligned

Correct vertical alignment

Fig. 6a

Shell and polar boss misaligned

Fig. 6b

Fig. 7b

Anti-rotational tabs

Fig. 7a

Fig. 8


Trial Reduction and Range of Motion

Note: The trial insert is used only to assess leg length and range of motion. It does not constrain the femoral head, as the actual implant does.

A trial femoral head with the appropriate neck length is placed on the trunion of the femoral component and reduced into the trial insert. After the leg length and femoral offset are verified, a trial range of motion is conducted. The key ranges of motion should be assessed (Fig. 9), specifically:

• Maximum flexion in neutral rotation

• Maximum internal rotation with 90° of flexion

• Full extension (but not hyper-extension),

• Full external rotation in full extension.

If the trial range of motion indicates that the orientation of the constraining fingers does not optimize the range of motion, such as might be indicated by premature impingement, the captured screw at the dome of the trial insert can be released and the trial insert rotated to another position. Once the optimum orientation of the trial insert is determined, the position of the center of the constraining fingers, shown by an engraved line, is noted on the acetabular shell. This mark will aid in reproducing the location of the constraining fingers with the implant (Fig. 10).

Fig. 10

Neutral Position. To optimize Range of Motion, the superior finger is placed at 1 o’clock for a left hip, and 11 o’clock on a right hip

External rotation in extension

Flexion plus internal rotation Full flexion

Fig. 9Trial Reduction Range of Motion


Liner Insertion

Remove the liner provisional and, after cleaning and drying the shell interior, place the Trilogy Longevity Constrained Liner into the shell making sure that the constraining fingers of the constrained liner are aligned in the acetabular shell to replicate the orientation that had provided optimum range of motion during assessment using the trial insert.

Note: Do not seat the Trilogy Longevity Constrained Liner in a position that allows the anti-rotation tabs on the acetabular shell to fit within the large cut-outs located at the base of each constraining finger (Fig. 11a). The smaller cut-outs located at the outermost portion of the liner rim are designed to mate with the acetabular shell anti-rotation tabs. The large cut-outs at the base of each constraining ring are designed to accept the large titanium pegs found on the underside of the constraining ring (Fig. 11b). The titanium pegs on the constraining ring provide the anti-rotation mechanism for the constraining ring.

When a poly liner exchange is planned with a well-fixed Trilogy or Trabecular Metal modular acetabular shell, preoperative radiographic assessment may be helpful in determining the location of the shell anti-rotation tabs.

Fig. 11a

Fig. 11b


The appropriately sized Liner Impactor Head is threaded onto the Impactor Handle until the threads are completely seated. The impactor is placed inside the liner and a force is applied to seat the liner within the shell (Fig. 12). The shell locking ring tabs will open and then close together. The Trilogy Longevity Constrained Liner is fully seated when there is a 2mm to 3mm gap between the shell locking ring tabs, and they can be moved from side-to-side with a probe. The shell locking ring serves to secure the liner in place. It must float freely inside the shell to function properly.

Note: Do not use the standard 28, 32, and 36mm Trilogy Liner Impactors as they may damage the constraining fingers of the constrained liner.

Fig. 12

�0 Trilogy Longevity Constrained Liner

Implant AssemblyPreparation of Constraining Ring

To assemble the Trilogy Longevity Constrained Liner, place the metal reinforcing ring over the head of the femoral component in the proper orientation (Fig. 13). The top-side of the ring with the two protruding fingers must point toward the femur. The under-side of the ring, which will contact the face of the polyethylene liner, must be toward the patient’s acetabulum.

Note: For clarification, the ring is engraved with “TOWARDS FEMUR” and “TOWARDS ACETABULUM” (Fig. 14).

Femoral Head Reduction

Note: The metal constraining ring must be in place around the femoral neck before reducing the head into the liner.

Reduce the appropriately sized femoral head into the Trilogy Longevity Constrained Liner by applying a continuous, steady force axially along the femur (Fig. 15). Attempts should not be made to reduce the femoral head into the insert with a sudden impaction force. Sudden impaction actually requires a higher force to be applied.

Fig. 15

Fig. 13

Fig. 14

��Trilogy Longevity Constrained Liner

Constraining Ring Assembly to Insert

To attach the metal constraining ring to the insert, advance the ring from around the femoral neck to the face of the insert. To ensure proper alignment of the ring, the titanium pegs on the flat side of the reinforcement ring must fit into the slots on the outside of the polyethylene liner. When properly positioned, the fingers on the metal ring are aligned with the fingers on the polyethylene liner (Fig. 16).

An appropriately sized Ring Impactor is threaded onto the Impactor Handle until the threads are completely seated. The posts of the Ring Impactor are inserted into the holes on the constraining ring (Fig. 17). Two or three moderate impaction blows are applied with a surgical mallet to seat the ring onto the insert (Fig. 18).

Note: The Ring Impactors are sized according to the inner diameter of the insert (28, 32, and 36mm).

Note: Soft tissue must be cleared from the periphery of the polyethylene insert in order to avoid trapping of the soft tissue between the insert and the metal constraining ring. This trapping of soft tissue may result in difficulty seating the insert into the shell. If difficulty assembling the ring is encountered, check the periphery for soft tissue impingement. After assembling the constraining ring to the insert, the range of motion is re-checked, and joint stability is checked by applying traction on the femur. If both range of motion and stability are satisfactory, closure of the wound proceeds as usual.

Fig. 16

Fig. 17

Fig. 18

�� Trilogy Longevity Constrained Liner

Implant Disassembly (If Required)

To remove the constraining ring, insert a flat instrument, such as a quarter-inch osteotome, under the ring (Fig. 19). Apply rotational torque to the instrument in order to pry the constraining ring from the polyethylene snap feature. Carefully repeat this process at a few sites around the periphery of the ring until the ring is loosened from the insert.

Note: Do not reuse liner or ring if the part has been disassembled.

Follow standard Trilogy or Trabecular Metal Modular liner removal procedure for liner extraction.

Fig. 19


IndicationsThe Trilogy Longevity Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

Contraindications• The Trilogy Longevity Constrained Liner

is contraindicated for use with skirted femoral heads due to reduced range of motion, and increased possibility of impingement and subsequent dislocation of the device.

• The Trilogy Longevity Constrained Liner is also contraindicated for use in the following conditions:

- Active or unresolved local or systemic infection

- Osteoradionecrosis of the acetabulum

- Skeletal immaturity

Warnings• This product should only be used with a

well-fixed Trabecular Metal Modular or Trilogy acetabular shell. Ancillary screw fixation of the shell is strongly recommended to assist in maintaining fixation at the shell/bone interface.

• The Trilogy Longevity Constrained Liner and metal acetabular shell must be properly aligned to prevent impingement of the liner and femoral neck. Careful attention to position and range of motion must be observed. Impingement may lead to dislocation of the femoral head from the constrained liner.

• To avoid impingement, do not use a Trilogy Longevity Constrained Liner with any femoral component or femoral head where the passive range of motion is less than 90°.

This includes some collared stems and 6 degree femoral heads designated “short.” Provisional (trial) components must be used to confirm adequate range of motion of a particular stem/head/liner combination prior to making the final decision to implant a Trilogy Longevity Constrained Liner.

• Assemble the constraining ring on the constrained acetabular liner only once. If the device is not assembled correctly, it should be removed and replaced with a new liner and constraining ring.

• Closed reduction of this device is not possible. Treatment of device dislocation will require additional surgery.

• Do not implant the Trilogy Longevity Constrained Liner without the reinforcing ring assembled.

• Ring failure has been reported for similar devices. Proper monitoring should be conducted. If ring failure or dissociation is observed, additional surgery may be required.

• Where there is insufficient acetabular bone stock, bone grafting or other adjunctive reinforcement procedures to provide socket support and cup containment are recommended.

• Do not use the Trilogy Longevity Constrained Liner with components of other manufacturers. Combining products of different manufacturers may lead to impingement, premature wear or failure of the device.

• This device is for single patient use only. Do not reuse.

• Do not use this product for other than

labeled indications (off-label use).

Precautions• Do not use implant components (femoral

heads or acetabular liners) to perform trial reductions. To avoid damaging implants, provisional femoral heads should only be mated with provisional liners and provisional liners should only be mated with provisional heads.

• To facilitate proper assembly, components must be at room temperature before implantation.

Postoperative Care, Indications, Contraindications and Warnings

• To correctly position the metallic locking ring, surgeons should consult the manufacturer’s instructions for appropriate device assembly.

• Compatible constraining rings and constrained liners are packaged together and must be used together. Do not mix liners and rings from different packages.

Adverse EffectsThe following adverse effects have been reported for total hip arthroplasty:

• Early or late component loosening

• Component failure or fracture

• Component dislocation and/or migration

• Infection

• Metal sensitivity

• Inflammatory reaction and osteolysis

• Heterotopic bone formation, ankylosis, and reduced mobility

• Perforation of the acetabulum

• Wear

• Vascular complications

• Disassembly of modular components

• Pelvic or acetabular fractures

• Subclinical nerve damage

Patient Counseling InformationThis prosthesis will not restore function to the level expected with a normal healthy joint, and the patient should be instructed as to the limitations of the device. The range of motion achievable with a constrained liner is less than the range of motion of a normal joint, and less than with a semi-constrained prosthesis. The patient should be told that, although the constrained liner provides resistance to dislocation, it can dislocate if subjected to excessive loading. Once dislocated, additional surgery will be required to reduce the joint.

Patients should be instructed that significant reduction in the range of motion is inherent to the design characteristics of a constrained acetabular liner, and activities that may force the joint to exceed those range of motion limits should be avoided.


Trilogy Longevity Constrained Liners (Includes Constraining Ring)

Cat. No. Description

00-6334-050-28 Trilogy Longevity Constrained Liner 50/52/54mm OD x 28mm ID

00-6334-056-32 Trilogy Longevity Constrained Liner 56mm OD x 32mm ID













Ordering Information

Trilogy Longevity Constrained Liner Instruments


00-6144-000-00 Trilogy Longevity Constrained Liner Instrument Kit (includes one each of the items listed below)

00-6144-095-00 Trilogy Longevity Constrained Liner Instrument Case (includes base, tray, and lid)

00-6144-050-28 Trilogy Longevity Constrained Liner Provisional OD x ID 50,52, 54 x 28

00-6144-056-32 Trilogy Longevity Constrained Liner Provisional OD x ID 56 x 32








9340-00-000 Impactor Handle

00-6144-001-28 Constraining Ring Impactor 28mm



00-6144-002-28 Liner Impactor Head 28mm



Trilogy Longevity Constrained Liner Jumbo Liner Provisionals


00-6144-000-01 Trilogy Longevity Constrained Liner Jumbo Provisionals Kit (includes one each of the items listed below) (fits within case #00-6144-095-00)







Trilogy Bone Screws


00-6250-045-15 Bone Screw 4.5mm x 15mm, Self-Tap
















Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Trilogy Holed Instruments


00-6260-099-02 Trilogy Holed Instrument Set (Set includes one each of the items listed below)

00-6260-085-01 Instrument Case (includes base and lid)

00-6260-002-00 Flex Shaft with Modular Connector

00-6260-003-01 Drill Bit, 15mm

00-6260-003-02 Drill Bit, 30mm

00-6260-003-03 Drill Bit, 45mm

00-6260-006-00 Drill Guide

00-6260-007-01 Tap, 4.5mm

00-6260-007-02 Tap, 6.5mm

00-6260-008-01 Tap Guide, 4.5mm

006260-008-02 Tap Guide, 6.5mm

00-6260-10-00 Tap Handle

00-6260-013-00 Screw Holding Forceps, 15°

00-6260-014-00 Screw Holding Forceps, 45°

006260-024-00 Straight Screwdriver

00-6260-025-00 Universal Screwdriver

00-6260-026-00 Modular Universal Handle

00-6611-098-00 Depth Gauge

00-4215-200-00 Screwdriver Torque Limiter (ordered separately, not in kit)

Liner Removal Instruments

(Included in Trilogy Non-Holed Instrument Set, 00-6260-099-01)


00-6260-030-01 Disassembly Device

00-6260-035-01 Liner Extractor

00-6260-040-00 Liner Elevator


1 Paterno SA, Lachiewicz PF, Kelley SS. The influence of patient-related factors and position of the acetabular component on the rate of dislocation after total hip replacement. JBJS (Am). 1997; 79(8):1202-10.

2 Callaghan JJ, Heithoff BE, Boetz DD, Sullivan PM, Pederson DR, Johnston RC. Prevention of dislocation after hip arthroplasty. Clin Orthop. 2001; 393:157-62.

3 Etienne A, Cupic Z, Charnley J. Postoperative dislocation after Charnley low-friction arthroplasty. Clin Orthop. 1978; 132:19-23.

4 Lombardi AV Jr, Mallory TH, Karus TJ, Vaughn BK. Preliminary report on the S-ROM constraining acetabular insert: a retrospective clinical experience. Orthop. 1991, Mar; 14(3):297-303.

5 Woo RY, Morrey BF. Dislocations after total hip arthroplasty JBJS. 1982; 64-A(9):1295-1306.6 Fisher DA, Kiley K. Constrained acetabular cup disassembly. J Arthroplasty. 1994, Jun; 9(3):325-9.7 Kaper BP, Bernini PM. Failure of a constrained acetabular prosthesis of a total hip arthroplasty.

A report of four cases. JBJS (Am). 1998, Apr; 80(4):561-5.8 Anderson MJ, Murray WR, Skinner HB. Constrained acetabular components.

J Arthroplasty. 1994, Feb; 9(1):17-23.9 Yamaguchi M, Akisue T, Bauer TW, Hashimoto Y. The spatial location of impingement in total hip arthroplasty.

J Arthroplasty. 2000, Apr; 15(3):305-13. 10 Data on file at Zimmer11 Grobbelaar CJ, Du Plessis TA, Marais F. The radiation improvement of polyethylene prosthesis.

J Bone Joint Surg. 1978;60-B(3):370-374.12 Oonishi H, Kuno M, Ikada Y, et al. Super low wear crosslinked UHMWPE by heavy high-dose gamma radiation.

Proceedings from the 2nd Congress of Hip Section of Western Pacific Orthopaedic Assn. 1996;4.13 Sporer SM, Callaghan JJ, Olejniczak JP, et al. Hybrid total hip arthroplasty in patients under the age of fifty: A five-to-ten year follow-up. J Arthroplast y. 1998 ; 13(5): 485-491.14 Berger RA, Jacobs JJ, Quigley LR, et al. Primary cementless acetabular reconstruction in patients younger than

50 years old: 7-11 year results. Clin Orthop Rel Res. 1997;344:216-226.

References

Contact your Zimmer representative or visit us at www.zimmer.com

Please refer to the package insert for product information, including contraindications, warnings, and precautionary information.

+H124976334002001/$072407G07

97-6334-002-00 2.5ML Printed in USA ©2007 Zimmer, Inc.

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