Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component
Aims: A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std;...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
The British Editorial Society of Bone & Joint Surgery
2024-01-01
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| Series: | Bone & Joint Open |
| Subjects: | |
| Online Access: | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.51.BJO-2023-0121 |
| _version_ | 1797341737061974016 |
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| author | Thomas R. Turgeon Edward Vasarhelyi James Howard Matthew Teeter Christiaan H. Righolt Trevor Gascoyne Eric Bohm on behalf of the Canadian RSA Network |
| author_facet | Thomas R. Turgeon Edward Vasarhelyi James Howard Matthew Teeter Christiaan H. Righolt Trevor Gascoyne Eric Bohm on behalf of the Canadian RSA Network |
| author_sort | Thomas R. Turgeon |
| collection | DOAJ |
| description | Aims: A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Methods: Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits. Results: The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m2 (SD 6 kg/m2). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively). Conclusion: Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening. Cite this article: Bone Jt Open 2024;5(1):20–27. |
| first_indexed | 2024-03-08T10:22:19Z |
| format | Article |
| id | doaj.art-0c71c27bd650454c9413dfee983c371e |
| institution | Directory Open Access Journal |
| issn | 2633-1462 |
| language | English |
| last_indexed | 2024-03-08T10:22:19Z |
| publishDate | 2024-01-01 |
| publisher | The British Editorial Society of Bone & Joint Surgery |
| record_format | Article |
| series | Bone & Joint Open |
| spelling | doaj.art-0c71c27bd650454c9413dfee983c371e2024-01-27T12:16:40ZengThe British Editorial Society of Bone & Joint SurgeryBone & Joint Open2633-14622024-01-0151202710.1302/2633-1462.51.BJO-2023-0121Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial componentThomas R. Turgeon0https://orcid.org/0000-0002-1605-0753Edward Vasarhelyi1https://orcid.org/0000-0001-9942-9605James Howard2https://orcid.org/0000-0002-8118-0589Matthew Teeter3https://orcid.org/0000-0002-3911-3171Christiaan H. Righolt4https://orcid.org/0000-0002-8472-932XTrevor Gascoyne5Eric Bohm6https://orcid.org/0000-0002-3973-0794on behalf of the Canadian RSA NetworkConcordia Joint Replacement Group, Winnipeg, Manitoba, CanadaLondon Health Sciences Centre, London, Ontario, CanadaLondon Health Sciences Centre, London, Ontario, CanadaLondon Health Sciences Centre, London, Ontario, CanadaDepartment of Surgery, University of Manitoba, Winnipeg, Manitoba, CanadaOrthopaedic Innovation Centre, Winnipeg, Manitoba, CanadaConcordia Joint Replacement Group, Winnipeg, Manitoba, CanadaAims: A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Methods: Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits. Results: The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m2 (SD 6 kg/m2). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively). Conclusion: Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening. Cite this article: Bone Jt Open 2024;5(1):20–27.https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.51.BJO-2023-0121radiostereometrytotal knee arthroplastyknee replacementmigrationstabilitytibiatibial componentsrandomized controlled trialtotal knee arthroplasty (tka)radiostereometric analysis (rsa)patient-reported outcome measures (proms)tibial implantaseptic looseningbmicemented total knee arthroplastybone cement |
| spellingShingle | Thomas R. Turgeon Edward Vasarhelyi James Howard Matthew Teeter Christiaan H. Righolt Trevor Gascoyne Eric Bohm on behalf of the Canadian RSA Network Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component Bone & Joint Open radiostereometry total knee arthroplasty knee replacement migration stability tibia tibial components randomized controlled trial total knee arthroplasty (tka) radiostereometric analysis (rsa) patient-reported outcome measures (proms) tibial implant aseptic loosening bmi cemented total knee arthroplasty bone cement |
| title | Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component |
| title_full | Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component |
| title_fullStr | Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component |
| title_full_unstemmed | Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component |
| title_short | Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component |
| title_sort | randomized controlled trial comparing traditional versus enhanced fixation designs of a novel cemented total knee arthroplasty tibial component |
| topic | radiostereometry total knee arthroplasty knee replacement migration stability tibia tibial components randomized controlled trial total knee arthroplasty (tka) radiostereometric analysis (rsa) patient-reported outcome measures (proms) tibial implant aseptic loosening bmi cemented total knee arthroplasty bone cement |
| url | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.51.BJO-2023-0121 |
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