Traditional Versus Alternative Alignment in TKR

NCT03196011 | Active Not Recruiting DMC

• 1 other identifier: 1802588
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

As many as 20% of patients are unhappy with the results of total knee replacement (TKR). Various changes to surgical technique have tried to address this but have not led to a significant improvement in the numbers of patients satisfied with their operation. Recently, attention has focussed on alignment of the leg. When viewed from the front, a number of people do not start with a straight, mechanically aligned leg. Traditionally, when implanting a knee replacement, the surgeon tries to put the shin bone half of the knee replacement perpendicular to the floor to equalise stresses on the in and outside of the joint. However, this may result in the alignment of the leg changing considerably, straining the soft tissues around the knee and contributing to dissatisfaction with TKR. There has been a move by some surgeons to change practice, and to implant the TKR in a way that replicates the alignment of the patient's own original knee- alternative alignment. Studies looking at alternative alignment have not shown any loss of satisfaction with results of TKR and indeed are showing some signs that in the short term, function of the knee may be better with the new technique. The research team are planning to run a study comparing the knee replacement used in Exeter- the Triathlon- when put in place using traditional alignment versus using the alternative alignment methods. The outcomes will be assessed in various ways including patient satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The research team will look at short term results for satisfaction and function of the knee, and in the long term look at wear and survivorship to see if patient satisfaction with TKR can be improved.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• The assessment of difference in knee joint function between the 2 study groups as measured by the Oxford Knee Score.(OKS)

  The OKS is a validated condition specific outcome measure tool.

  1 year after surgery

Secondary Outcomes (45)

• An assessment of any significant differences between the 2 arms of the study in limb alignment measured on the full leg alignment X-rays

  1 year after surgery

• An assessment of any significant differences between the 2 arms of the study in component positioning measured on the full leg alignment x-ray

  1 year after surgery

• An assessment of any significant differences between the 2 arms of the study of positioning of the implants and of joint line position measured on CT scan

  6 weeks after surgery

• An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee

  6 weeks after surgery

• An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee

  3 months after surgery

Other Outcomes (1)

• An assessment of any significant differences between the 2 arms of the study when comparing the hospital costs of knee replacement surgery

  Study data will be analysed 1 year after discharge from hospital of the last participant- i.e. 3 years after commencement of study.

Study Arms (2)

TKR with mechanical alignment

ACTIVE COMPARATOR

TKR implanted using traditional alignment methods

Other: TKR with mechanical alignment method

TKR using alternative alignment method

EXPERIMENTAL

TKR implanted using alternative alignment methods

Other: TKR with alternative alignment method

Interventions

TKR with mechanical alignment method OTHER

TKR implanted using traditional mechanical alignment methods

TKR with mechanical alignment

TKR with alternative alignment method OTHER

TKR implanted using alternative alignment methods

TKR using alternative alignment method

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have completed a consent form for the study
• Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
• Patient in whom any varus deformity present is \<20°
• The diagnosis is of tricompartmental osteoarthritis of the knee
• Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• BMI\<40
• Aged =/\> 60 years at time of surgery

You may not qualify if:

• If the knee for surgery has a fixed flexion deformity ≥15°- this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery
• If the knee for surgery has a varus deformity ≥20°
• If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle \<0°
• Pre-op Oxford Knee Score \<8
• Pre-op knee flexion ability \<90°
• If the natural posterior tibial slope measured is in excess of 10°
• Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions
• Pregnancy
• Prisoners
• A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
• Patients unable to read or understand the patient information leaflet and consent form
• Patient has a known sensitivity to device materials.
• Patient has a Body Mass Index (BMI) ≥ 40.
• Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
• Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• Stryker Nordic: collaborator

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX25DW, United Kingdom

Location

Related Publications (11)

• Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.

  PMID: 16967035 BACKGROUND

• Calliess T, Bauer K, Stukenborg-Colsman C, Windhagen H, Budde S, Ettinger M. PSI kinematic versus non-PSI mechanical alignment in total knee arthroplasty: a prospective, randomized study. Knee Surg Sports Traumatol Arthrosc. 2017 Jun;25(6):1743-1748. doi: 10.1007/s00167-016-4136-8. Epub 2016 Apr 27.

  PMID: 27120192 BACKGROUND

• Parratte S, Pagnano MW, Trousdale RT, Berry DJ. Effect of postoperative mechanical axis alignment on the fifteen-year survival of modern, cemented total knee replacements. J Bone Joint Surg Am. 2010 Sep 15;92(12):2143-9. doi: 10.2106/JBJS.I.01398.

  PMID: 20844155 BACKGROUND

• Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.

  PMID: 21656315 BACKGROUND

• Bonner TJ, Eardley WG, Patterson P, Gregg PJ. The effect of post-operative mechanical axis alignment on the survival of primary total knee replacements after a follow-up of 15 years. J Bone Joint Surg Br. 2011 Sep;93(9):1217-22. doi: 10.1302/0301-620X.93B9.26573.

  PMID: 21911533 BACKGROUND

• Waterson HB, Clement ND, Eyres KS, Mandalia VI, Toms AD. The early outcome of kinematic versus mechanical alignment in total knee arthroplasty: a prospective randomised control trial. Bone Joint J. 2016 Oct;98-B(10):1360-1368. doi: 10.1302/0301-620X.98B10.36862.

  PMID: 27694590 BACKGROUND

• Mizner RL, Stevens JE, Snyder-Mackler L. Voluntary activation and decreased force production of the quadriceps femoris muscle after total knee arthroplasty. Phys Ther. 2003 Apr;83(4):359-65.

  PMID: 12665406 BACKGROUND

• Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

  PMID: 20710093 BACKGROUND

• Dossett HG, Swartz GJ, Estrada NA, LeFevre GW, Kwasman BG. Kinematically versus mechanically aligned total knee arthroplasty. Orthopedics. 2012 Feb 17;35(2):e160-9. doi: 10.3928/01477447-20120123-04.

  PMID: 22310400 BACKGROUND

• Clement ND, MacDonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1933-9. doi: 10.1007/s00167-013-2776-5. Epub 2013 Nov 20.

  PMID: 24253376 BACKGROUND

• Sheen J, Abdul W, Corroon C, Waterson B, Toms A. Alternative alignment clinical study: study protocol for a prospective, randomised, controlled study of the outcomes and cost effectiveness of triathlon CR knee replacement system: traditional philosophy versus alternative alignment philosophy. J Orthop Surg Res. 2025 Dec 5;21(1):27. doi: 10.1186/s13018-025-06551-z.

  PMID: 41351159 DERIVED

MeSH Terms

Interventions

tokaratoxin 2

Study Officials

• Andrew Toms, MSc FRCS

  Royal Devon and Exeter Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, randomised controlled trial with 2 intervention arms

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: October 23, 2018
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)