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Clinical Trial
. 2020 Mar 9;15(3):e0230027.
doi: 10.1371/journal.pone.0230027. eCollection 2020.

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

R Atallah  1 , H van de Meent  2 , L Verhamme  3 , J P Frölke  4 , R A Leijendekkers  2   5
Affiliations
Clinical Trial

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

R Atallah et al. PLoS One. .

Abstract

Background: We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants.

Methods: All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up.

Results: Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening's occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25th to 75th PCTL) Q-TFA PUS and GS were 52±39, 52(7-90) and 40±19, 42(25-50) and improved significantly to 88±18, 90 (90-100) and 71±15, 75 (67-83) at one-year follow-up. The GS Q3 improved over time.

Conclusion: Titanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.

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Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: Henk van de Meent is a shareholder of OTN Implants BV Netherlands. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Preoperative planning and measurement of femoral remnant in OFI-C.
OFI-C: Osseointegration Femur Implant curved type, FL: Femur length.
Fig 2
Fig 2. Preoperative planning and measurement of femoral remnant in OFI-Y.
OFI-Y Osseointegration Femur Implant Gamma type, FL: Femur length.
Fig 3
Fig 3. Preoperative planning of tibial remnant in OTI.
OTI: Osseointegration Tibia implant, TL: Tibia length.
Fig 4
Fig 4. Schematic presentation of presurgical planning OFI-C.
OFI-C: Osseointegration femur implant curved type, DCA: Dual cone adapter, Heli connector produced by OTNInnovations.
Fig 5
Fig 5. Seal of intramedullary canal by drop-like shaped implant.
Fig 6
Fig 6. Dualcone adapter and internal locking screw.
Fig 7
Fig 7. Osseointegration implant connector (A: OTN connector, B: OPL/Hermle connector).
Fig 8
Fig 8. Participant flow diagram.
ILP: Integral leg prosthesis, OPL type B: Osseointegration prosthetic limb type B.
See this image and copyright information in PMC

References

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