Ligament Balancing in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

— BLIS-TKA  

Official title:

Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264076
• Other study ID #: 686340
• Secondary ID: CIV-NO-23-09-043
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: Lars HW Engseth, MD
• Phone: 004741254136
• Email: laengs[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

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

2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?

Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital.

Description:

Varus deformity is the most common deformity (60-80%) in patients undergoing total knee arthroplasty (TKA). In varus knees, there could be shortening of medial structures; therefore, if mechanical alignment is the goal, perpendicular bone cuts could produce a trapezoidal gap between the femur and tibia, with a shorter medial side. This imbalance should be corrected through ligament balancing as it is seen as a prerequisite for good function and survival. Aunan et al. found ligament balancing to be necessary in 70 of 100 consecutive TKAs.

Several ligament balancing techniques exist and most focus on lengthening the soft tissue on the concave side of the knee. Bellemans' and Whiteside's techniques are examples of ligament balancing procedures. In varus knees Bellemans' technique is performed with multiple perforations (pie-crusting) of the medial collateral ligament (MCL), while Whiteside's technique is performed with sequential ligament and soft tissue release, where the MCL is evaluated first. However, no technique has proved clinically superior to others. In traditional methods, it is difficult to reliably predict ligament lengthening and it relies on the performing surgeons' feel and experience. Aunan et al. found wide variation in lengthening achieved using Whiteside's technique. Therefore, the investigators have developed a novel device, which aspires to further develop Bellemans' technique and produce repeatable soft tissue lengthening of the MCL.

In varus knees the most important structure in ligament balancing is the superficial and deep MCL (hereafter MCL). Bellemans' technique is a proven technique, which uses an end-cutting cannula to puncture the MCL by freehand, with the objective of severing some ligament fibers. When the force applied to the ligament is kept constant, each remaining fiber will be exposed to a higher force and lengthen. Bellemans' technique lacks an objective method of guiding the puncturing, and the execution and results therefore vary. The novel instrument invented by the investigators, has a specific grid that objectively guides perpendicular puncturing using an end-cutting cannula and evenly distributes punctures throughout the ligament, which will produce a predefined spread of punctures and severing of fibers. The investigators believe this grid is key to achieving repeatable lengthening of the MCL, and promising results have been shown in porcine and human cadaveric tissue.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age under 40 years of age

• Pregnant

• Revisions or reoperations

• Considerable earlier injury to the knee

• Isolated patellofemoral osteoarthrosis

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Ligament; Laxity, Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Norway	Baerum Hospital, Vestre Viken Hospital Trust	Bærums Verk	Viken
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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. The investigators will evaluate if the lengthening is linear and repeatable between individuals using regression analysis.	1 year
Secondary	Demographic information - height (cm) - and how this parameters affects ligament balancing.	The investigators will evaluate if height in centimeters plays a role in how much ligament lengthening is achieved when using a novel instrument for systematic ligament balancing in MCL-lengthening. Evaluations will be done using regression analysis.	1 year
Secondary	Demographic information - weight (kg) - and how this parameters affects ligament balancing.	The investigators will evaluate if weight in kilograms plays a role in how much ligament lengthening is achieved when using a novel instrument for systematic ligament balancing in MCL-lengthening. Evaluations will be done using regression analysis.	1 year
Secondary	Demographic information - age (years) - and how this parameters affects ligament balancing.	The investigators will evaluate if age in years plays a role in how much ligament lengthening is achieved when using a novel instrument for systematic ligament balancing in MCL-lengthening. Evaluations will be done using regression analysis.	1 year
Secondary	Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.	The investigators will evaluate if biological sex, defined as male or female, plays a role in how much ligament lengthening is achieved when using a novel instrument for systematic ligament balancing in MCL-lengthening. Evaluations will be done using regression analysis.	1 year
Secondary	Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.	The investigators will evaluate if co-morbidities, defined as disease states (eg. heart-failure, chronic lung disease, rheumatoid arthritis, etc) plays a role in how much ligament lengthening is achieved when using a novel instrument for systematic ligament balancing in MCL-lengthening. Evaluations will be done using regression analysis.	1 year
Secondary	Patient reported outcome measures (PROM) using EQ-5D-5L	Standard protocol after total knee arthroplasty surgery at Baerum Hospital will be followed. It is standard practice to evaluate the patient health using self-assessement questionnaires at approximately 6 months. One of these questionnaires is called: EQ-5D-5L or EuroQol-5 dimension-5 Level questionnaire. It consists of 5 equally weighted dimensions with 5 equally weighted levels. The five dimensions that the questionnaire evaluates is divided into five levels of perceived problems (1-5). 1 indicates no problems and 5 indicates extreme problems. A higher level indicates more problems. The levels are combined in a 5-digit state. The minimum value is 11111 and the maximum values 55555. The combination of levels in the state indicates the severity of problems for the patient.	1 year
Secondary	Patient reported outcome measures (PROM) using FJS-12	Standard protocol after total knee arthroplasty surgery at Baerum Hospital will be followed. It is standard practice to evaluate the patients health using self-assessement questionnaires at approximately 6 months. One of these questionnaires is called: FJS-12 or Forgotten Joint Score 12 questions, is is designed to be used to asses artificial prosthesis awareness during daily activities following arthroplasty. The version for the knee will be used. It consists of 12 equally weighted questions that are answered on a five-level Likert scale from "never" to "mostly". Answers to each question are individually scored and summed to create a score (0-100). A low score indicates that the patient is very aware of their artificial joint and a high score indicates that the patients are very satisfied because the joint does not feel artificial.	1 year
Secondary	Patient reported outcome measures (PROM) using KOOS-12	Standard protocol after total knee arthroplasty surgery at Baerum Hospital will be followed. It is standard practice to evaluate the patients health using self-assessement questionnaires at approximately 6 months. One of these questionnaires is called: KOOS-12 or Knee Injury and Osteoarthritis Score 12 items. KOOS is one of the most used PROMs for evaluation conditions surrounding total knee arthroplasty. KOOS-12 contains 12 items (questions). Each question is scored from 0-4, with 0 indicating no problems and 4 extreme problem. However, an overall impact score is calculated (0-100) using the 12 questions, where 0 indicates the most problematic knee and 100 the best outcome.	1 year

External Links

•   National Joint Registry
•   Norwegian Arthroplasty Register. Report 2019 [cited 13.03.23].
•   The American Joint Replacement Registry Annual Report. American Academy of Orthopaedic Surgeons.