Persona Partial Knee Study

NCT04913987 | Unknown

• 1 other identifier: Ortho 18-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare functional and clinical outcomes of partial knee joint replacement using the Persona Partial Knee (PPK) and a standard care total knee replacement. Reported benefits of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) are less invasive surgery, less post-operative pain, quicker recovery, shorter inpatient stay, preservation of the anterior cruciate ligament (ACL), better knee function and lower risk of complications. Also, the PPK more closely matches the anatomy of knee and has more sizing options. These aim to allow the surgeon to reconstruct the knee to better match the native knee and achieve natural function. Little data exists which investigates biomechanical function of patients after UKA or comparisons between UKA and TKA and none investigating the PPK. Available data focuses on level walking which is not particularly challenging for these patients and is unlikely to highlight biomechanical differences between UKA and TKA. The investigators will investigate biomechanical differences between UKA and TKA during more challenging activities. These will mirror activities of everyday life: sitting into/rising from a chair, stepping, walking on a slope. The investigators will investigate level walking as all studies of this nature report these data. Unlike TKA, UKA retains the ACL. The soft tissues of the knee play a role in balance control and the investigators will assess this with single leg balancing. Biomechanical differences will be assessed using 3D motion analysis before and after surgery (6 and 12 months). Comparisons will be made within and between groups and between the patient groups and existing healthy data. Radiographic and patient reported outcomes (satisfaction, pain and functional abilities) will be investigated. Fifty patients will be recruited and randomised to undergo TKA or UKA. Only patients who are suitable for UKA will be recruited. Data for 25 healthy, matched controls from the investigator's existing healthy control database will be extracted.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Total knee arthroplasty; Partial knee arthroplasty; Unicondylar knee arthroplasty; Randomised controlled trial; Functional biomechanical assessment; Movement analysis; Gait analysis

Outcome Measures

Primary Outcomes (1)

• Knee flexion

  Maximum knee flexion in degrees during step descent measured using movement analysis

  12 months post-operatively

Secondary Outcomes (3)

• Radiographic assessment of component/bone interface stability

  12 months post-operatively

• Survivorship

  12 months

• Patient satisfaction: 5 point Likert scale

  12 months post-operatively

Other Outcomes (4)

• Patient reported outcome (Oxford Knee Score)

  12 months post-operatively

• Patient reported outcome (EuroQual 5D-5L questionnaire)

  12 months post-operatively

• Patient reported outcome (Forgotten Joint Score)

  12 months post-operatively

Study Arms (2)

Total knee

EXPERIMENTAL

Standard care

Device: Stryker Triathlon total knee replacement

Partial knee

EXPERIMENTAL

Intervention using relatively new partial knee.

Device: Zimmer Biomet Persona Partial Knee unicondylar knee replacement

Interventions

Stryker Triathlon total knee replacement DEVICE

Knee arthroplasty using a standard care total knee.

Total knee

Zimmer Biomet Persona Partial Knee unicondylar knee replacement DEVICE

Knee arthroplasty using the Zimmer Biomet Persona Partial Knee (PPK).

Also known as: Zimmer Biomet Persona Partial Knee (PPK)

Partial knee

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable for medial unicompartmental knee arthroplasty
• Aged between 18 and 75 years inclusive
• Taller than 1.5m in height (the 10th percentile for the population)
• Functionally intact anterior cruciate ligament
• Able to give informed consent
• Able to return to GJNH for follow-up
• BMI under 40

You may not qualify if:

• Inflammatory joint disease e.g. rheumatoid arthritis
• Previous hip procedure in the previous twelve months
• Previous knee surgery other than arthroscopy and medial menisectomy
• Previous ankle surgery
• Symptomatic foot, hip or spinal pathology
• Any medical condition limiting normal ambulation e.g. stroke, Charcot-Marie-Tooth disease, severe lymphedema, advanced cardiac disease
• Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

Location

Related Publications (20)

• Sculco TP. Orthopaedic crossfire--can we justify unicondylar arthroplasty as a temporizing procedure? in opposition. J Arthroplasty. 2002 Jun;17(4 Suppl 1):56-8. doi: 10.1054/arth.2002.32687.

  PMID: 12068406 BACKGROUND

• Deshmukh RV, Scott RD. Unicompartmental knee arthroplasty: long-term results. Clin Orthop Relat Res. 2001 Nov;(392):272-8.

  PMID: 11716395 BACKGROUND

• Alnachoukati OK, Barrington JW, Berend KR, Kolczun MC, Emerson RH, Lombardi AV Jr, Mauerhan DR. Eight Hundred Twenty-Five Medial Mobile-Bearing Unicompartmental Knee Arthroplasties: The First 10-Year US Multi-Center Survival Analysis. J Arthroplasty. 2018 Mar;33(3):677-683. doi: 10.1016/j.arth.2017.10.015. Epub 2017 Oct 16.

  PMID: 29113757 BACKGROUND

• Forster-Horvath C, Artz N, Hassaballa MA, Robinson JR, Porteous AJ, Murray JR, Newman JH. Survivorship and clinical outcome of the minimally invasive Uniglide medial fixed bearing, all-polyethylene tibia, unicompartmental knee arthroplasty at a mean follow-up of 7.3years. Knee. 2016 Dec;23(6):981-986. doi: 10.1016/j.knee.2016.07.003. Epub 2016 Aug 6.

  PMID: 27506988 BACKGROUND

• Braito M, Giesinger JM, Fischler S, Koller A, Niederseer D, Liebensteiner MC. Knee Extensor Strength and Gait Characteristics After Minimally Invasive Unicondylar Knee Arthroplasty vs Minimally Invasive Total Knee Arthroplasty: A Nonrandomized Controlled Trial. J Arthroplasty. 2016 Aug;31(8):1711-6. doi: 10.1016/j.arth.2016.01.045. Epub 2016 Feb 10.

  PMID: 26979765 BACKGROUND

• Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014 Oct 18;384(9952):1437-45. doi: 10.1016/S0140-6736(14)60419-0.

  PMID: 25012116 BACKGROUND

• Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. J Bone Joint Surg Br. 2001 Mar;83(2):191-4. doi: 10.1302/0301-620x.83b2.10966.

  PMID: 11284563 BACKGROUND

• Goodfellow J, O'Connor J. The anterior cruciate ligament in knee arthroplasty. A risk-factor with unconstrained meniscal prostheses. Clin Orthop Relat Res. 1992 Mar;(276):245-52.

  PMID: 1537161 BACKGROUND

• Deschamps G, Lapeyre B. [Rupture of the anterior cruciate ligament: a frequently unrecognized cause of failure of unicompartmental knee prostheses. Apropos of a series of 79 Lotus prostheses with a follow-up of more than 5 years]. Rev Chir Orthop Reparatrice Appar Mot. 1987;73(7):544-51. French.

  PMID: 3438510 BACKGROUND

• Banks SA, Fregly BJ, Boniforti F, Reinschmidt C, Romagnoli S. Comparing in vivo kinematics of unicondylar and bi-unicondylar knee replacements. Knee Surg Sports Traumatol Arthrosc. 2005 Oct;13(7):551-6. doi: 10.1007/s00167-004-0565-x. Epub 2005 Jan 20.

  PMID: 15660274 BACKGROUND

• Andriacchi TP, Galante JO, Fermier RW. The influence of total knee-replacement design on walking and stair-climbing. J Bone Joint Surg Am. 1982 Dec;64(9):1328-35. No abstract available.

  PMID: 7142241 BACKGROUND

• Komnik I, Peters M, Funken J, David S, Weiss S, Potthast W. Non-Sagittal Knee Joint Kinematics and Kinetics during Gait on Level and Sloped Grounds with Unicompartmental and Total Knee Arthroplasty Patients. PLoS One. 2016 Dec 21;11(12):e0168566. doi: 10.1371/journal.pone.0168566. eCollection 2016.

  PMID: 28002437 BACKGROUND

• Komnik I, Weiss S, Fantini Pagani CH, Potthast W. Motion analysis of patients after knee arthroplasty during activities of daily living--a systematic review. Gait Posture. 2015 Feb;41(2):370-7. doi: 10.1016/j.gaitpost.2015.01.019. Epub 2015 Jan 28.

  PMID: 25680471 BACKGROUND

• Jones GG, Kotti M, Wiik AV, Collins R, Brevadt MJ, Strachan RK, Cobb JP. Gait comparison of unicompartmental and total knee arthroplasties with healthy controls. Bone Joint J. 2016 Oct;98-B(10 Supple B):16-21. doi: 10.1302/0301-620X.98B10.BJJ.2016.0473.R1.

  PMID: 27694511 BACKGROUND

• Wiik AV, Aqil A, Tankard S, Amis AA, Cobb JP. Downhill walking gait pattern discriminates between types of knee arthroplasty: improved physiological knee functionality in UKA versus TKA. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1748-55. doi: 10.1007/s00167-014-3240-x. Epub 2014 Aug 27.

  PMID: 25160471 BACKGROUND

• Fu YC, Simpson KJ, Brown C, Kinsey TL, Mahoney OM. Knee moments after unicompartmental knee arthroplasty during stair ascent. Clin Orthop Relat Res. 2014 Jan;472(1):78-85. doi: 10.1007/s11999-013-3128-y.

  PMID: 23836240 BACKGROUND

• Shankar S, Tetreault MW, Jegier BJ, Andersson GB, Della Valle CJ. A cost comparison of unicompartmental and total knee arthroplasty. Knee. 2016 Dec;23(6):1016-1019. doi: 10.1016/j.knee.2015.11.012. Epub 2016 Oct 31.

  PMID: 27810433 BACKGROUND

• Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22.

  PMID: 19464898 BACKGROUND

• Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

  PMID: 16139163 BACKGROUND

• Fenner VU, Behrend H, Kuster MS. Joint Mechanics After Total Knee Arthroplasty While Descending Stairs. J Arthroplasty. 2017 Feb;32(2):575-580. doi: 10.1016/j.arth.2016.07.035. Epub 2016 Aug 13.

  PMID: 27642045 BACKGROUND

Study Officials

• Nichoas Ohlyl, FRCS Ed

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Consecutive patients placed in to one of two groups.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: June 4, 2021
• Study Start: April 26, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2025
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)