Ligament Balancing in Total Knee Arthroplasty

NCT06264076 | Recruiting DMC

• 2 other identifiers: 686340CIV-NO-23-09-043976
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:

1. 1.Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
2. 2.Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?

Conditions

Ligament; Laxity, Knee; Knee Osteoarthritis

Keywords

Total knee arthroplasty (TKA); Total Knee Replacement (TKR); Knee kinematics; Ligament balance; Bellemans; Soft-tissue balance

Outcome Measures

Primary Outcomes (2)

• Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?

  The investigators will be studying if it is possible to perform systematic ligament balancing on the MCL during total knee arthroplasty surgery, using a novel instrument.

  1 year

• MCL-lengthening in millimeters after ligament balancing using the novel instrument

  The investigators will be evaluating the amount of lengthening of the medial collateral ligament (MCL) in millimeters, that is achieved when using a novel instrument for systematic ligament balancing in total knee arthroplasty. Lengthening in millimeters is evaluated using computer navigated orthopaedic surgery (CAOS) and ligament tensioners or spatulas. The investigators will evaluate if the lengthening is linear and repeatable between individuals using regression analysis.

  1 year

Secondary Outcomes (9)

• Demographic information - height (cm) - and how this parameters affects ligament balancing.

  1 year

• Demographic information - weight (kg) - and how this parameters affects ligament balancing.

  1 year

• Demographic information - age (years) - and how this parameters affects ligament balancing.

  1 year

• Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.

  1 year

• Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.

  1 year

Study Arms (2)

Single interventional group at Bærum Hopsital Vestre Viken Hospital Trust

EXPERIMENTAL

Patients that need ligament balancing will receive the procedure using a novel instrument under knee arthroplasty surgery. BrainLab navigation will be used to evaluate ligament balancing. Performed av Bærum Hospital Vestre Viken Hospital Trust

Device: A novel instrument for ligament balancing in total knee arthroplasty

Single interventional group at OUH Ullevål Hospital

EXPERIMENTAL

Singel group non-blin interventional study group receiving ligament balancing performed using a novel instrument. Ligament balancing will be evaluated using conventional instruments.

Device: Novel Instrument for ligament balancing in knee arthroplasty

Interventions

A novel instrument for ligament balancing in total knee arthroplasty DEVICE

Patients will be evaluated perioperatively for ligament balance. When indicated, the novel instrument will guide puncturing of the medial collateral ligament in a systematic and step-wise fashion. Achieved ligament balance will be observed and controlled by computer navigation and a ligament tensor. Performed at Bærum Hospital vestre Viken Hospital Trust.

Single interventional group at Bærum Hopsital Vestre Viken Hospital Trust

Novel Instrument for ligament balancing in knee arthroplasty DEVICE

Patients will be evaluated perioperatively for ligament balance. When indicated, the novel instrument will guide puncturing of the medial collateral ligament in a systematic and step-wise fashion. Achieved ligament balance will be observed and controlled by conventional methods using spatulas.

Single interventional group at OUH Ullevål Hospital

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 40 years of age that require total knee arthroplasty
• Idiopathic osteoarthrosis, osteonecrosis or avascular osteonecrosis
• Otherwise fairly healthy/ no significant health issues

You may not qualify if:

• Age under 40 years of age
• Pregnant
• Revisions or reoperations
• Considerable earlier injury to the knee
• Isolated patellofemoral osteoarthrosis

Sponsors & Collaborators

• Oslo University Hospital: lead
• Vestre Viken Hospital Trust: collaborator

Study Sites (2)

Bærum Hospital, Vestre Viken Hospital Trust

Bærums verk, Akershus, 1346, Norway

COMPLETED

Oslo University Hospital, Ullevaal

Oslo, Oslo County, 0450, Norway

RECRUITING

Related Publications (18)

• Verdonk PC, Pernin J, Pinaroli A, Ait Si Selmi T, Neyret P. Soft tissue balancing in varus total knee arthroplasty: an algorithmic approach. Knee Surg Sports Traumatol Arthrosc. 2009 Jun;17(6):660-6. doi: 10.1007/s00167-009-0755-7. Epub 2009 Mar 17.

  PMID: 19290507 BACKGROUND

• Bellemans J. Multiple needle puncturing: balancing the varus knee. Orthopedics. 2011 Sep 9;34(9):e510-2. doi: 10.3928/01477447-20110714-48.

  PMID: 21902147 BACKGROUND

• Bellemans J, Vandenneucker H, Van Lauwe J, Victor J. A new surgical technique for medial collateral ligament balancing: multiple needle puncturing. J Arthroplasty. 2010 Oct;25(7):1151-6. doi: 10.1016/j.arth.2010.03.007. Epub 2010 May 10.

  PMID: 20452181 BACKGROUND

• Aunan E, Kibsgard T, Clarke-Jenssen J, Rohrl SM. A new method to measure ligament balancing in total knee arthroplasty: laxity measurements in 100 knees. Arch Orthop Trauma Surg. 2012 Aug;132(8):1173-81. doi: 10.1007/s00402-012-1536-1. Epub 2012 May 13.

  PMID: 22581351 BACKGROUND

• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.

  PMID: 23973124 BACKGROUND

• Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.

  PMID: 22357571 BACKGROUND

• Aunan E, Rohrl SM. No detrimental effect of ligament balancing on functional outcome after total knee arthroplasty: a prospective cohort study on 129 mechanically aligned knees with 3 years' follow-up. Acta Orthop. 2018 Oct;89(5):548-554. doi: 10.1080/17453674.2018.1485283. Epub 2018 Jun 8.

  PMID: 29883259 BACKGROUND

• Whiteside LA. Soft tissue balancing: the knee. J Arthroplasty. 2002 Jun;17(4 Suppl 1):23-7. doi: 10.1054/arth.2002.33264.

  PMID: 12068398 BACKGROUND

• Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009 Sep;24(6 Suppl):39-43. doi: 10.1016/j.arth.2009.04.034. Epub 2009 Jun 24.

  PMID: 19553073 BACKGROUND

• Abdel MP, Ollivier M, Parratte S, Trousdale RT, Berry DJ, Pagnano MW. Effect of Postoperative Mechanical Axis Alignment on Survival and Functional Outcomes of Modern Total Knee Arthroplasties with Cement: A Concise Follow-up at 20 Years. J Bone Joint Surg Am. 2018 Mar 21;100(6):472-478. doi: 10.2106/JBJS.16.01587.

  PMID: 29557863 BACKGROUND

• Magnussen RA, Weppe F, Demey G, Servien E, Lustig S. Residual varus alignment does not compromise results of TKAs in patients with preoperative varus. Clin Orthop Relat Res. 2011 Dec;469(12):3443-50. doi: 10.1007/s11999-011-1988-6. Epub 2011 Jul 26.

  PMID: 21789710 BACKGROUND

• Babazadeh S, Stoney JD, Lim K, Choong PF. The relevance of ligament balancing in total knee arthroplasty: how important is it? A systematic review of the literature. Orthop Rev (Pavia). 2009 Oct 10;1(2):e26. doi: 10.4081/or.2009.e26.

  PMID: 21808688 BACKGROUND

• Mihalko WM, Whiteside LA, Krackow KA. Comparison of ligament-balancing techniques during total knee arthroplasty. J Bone Joint Surg Am. 2003;85-A Suppl 4:132-5. doi: 10.2106/00004623-200300004-00018. No abstract available.

  PMID: 14652405 BACKGROUND

• Robinson JR, Bull AM, Amis AA. Structural properties of the medial collateral ligament complex of the human knee. J Biomech. 2005 May;38(5):1067-74. doi: 10.1016/j.jbiomech.2004.05.034.

  PMID: 15797588 BACKGROUND

• Koh IJ, Kwak DS, Kim TK, Park IJ, In Y. How effective is multiple needle puncturing for medial soft tissue balancing during total knee arthroplasty? A cadaveric study. J Arthroplasty. 2014 Dec;29(12):2478-83. doi: 10.1016/j.arth.2013.11.004. Epub 2013 Nov 9.

  PMID: 24360488 BACKGROUND

• Engseth LHW, Gronsund J, Aunan E, Brattgjerd JE, Schulz A, Moatshe G, Rohrl SM. A novel instrument for ligament balancing: a biomechanical study in human cadaveric knees. J Exp Orthop. 2023 Aug 16;10(1):83. doi: 10.1186/s40634-023-00643-7.

  PMID: 37584812 BACKGROUND

• Liu F, Yue B, Gadikota HR, Kozanek M, Liu W, Gill TJ, Rubash HE, Li G. Morphology of the medial collateral ligament of the knee. J Orthop Surg Res. 2010 Sep 16;5:69. doi: 10.1186/1749-799X-5-69.

  PMID: 20846377 BACKGROUND

• Aglietti P, Lup D, Cuomo P, Baldini A, De Luca L. Total knee arthroplasty using a pie-crusting technique for valgus deformity. Clin Orthop Relat Res. 2007 Nov;464:73-7. doi: 10.1097/BLO.0b013e3181591c48.

  PMID: 17975373 BACKGROUND

Related Links

• National Joint Registry
• The American Joint Replacement Registry Annual Report. American Academy of Orthopaedic Surgeons.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Lars HW Engseth, MD

  Oslo University Hospital, Ullevaal, Oslo, Norway

  PRINCIPAL INVESTIGATOR

• Jarle Vik, MD

  Baerum Hospital, Vestre Viken Hospital Trust, Baerum, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars HW Engseth, MD

CONTACT

004741254136; laengs@ous-hf.no

Jarle Vik, MD

CONTACT

004793844926; jarle.vik@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Non-blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, orthopaedic consultant

Model Details: Prospective, single-group, non-blind, interventional study

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)