Ligament; Laxity, KneeBLIS-TKANCT06264076
Ligament Balancing in Total Knee Arthroplasty
A study testing A novel instrument for ligament balancing in total knee arthroplasty and Novel Instrument for ligament balancing in knee arthroplasty in people with Ligament; Laxity, Knee and Knee Osteoarthritis, run by Oslo University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ligament; Laxity, Knee, Knee Osteoarthritis
- What is being tested?
- A novel instrument for ligament balancing in total knee arthroplasty and Novel Instrument for ligament balancing in knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 40 years of age
- Pregnant
- Revisions or reoperations
- Considerable earlier injury to the knee
- Isolated patellofemoral osteoarthrosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 1 recruiting
- Completed
Bærum Hospital, Vestre Viken Hospital Trust
Bærums verk, Akershus, 1346
- Recruiting
Oslo University Hospital, Ullevaal
Oslo, Oslo, 0450
Lars HW Engseth, MD, 004741254136, laengs@ous-hf.no
About this study
Official title: Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique
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:
- Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
- 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.
Read the detailed 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.
- Conditions
- Ligament; Laxity, Knee, Knee Osteoarthritis
- Being tested
- A novel instrument for ligament balancing in total knee arthroplasty, Novel Instrument for ligament balancing in knee arthroplasty
- Keywords
- Total knee arthroplasty (TKA), Total Knee Replacement (TKR), Knee kinematics, Ligament balance, Bellemans, Soft-tissue balance
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel instrument for ligament balancing in total knee arthroplastyDevice
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.
Novel Instrument for ligament balancing in knee arthroplastyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Novel Instrument for ligament balancing in knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (9)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Patient reported outcome measures (PROM) using KOOS
Standard protocol for Bærum Hospital and the Norwegian Registry after total knee arthroplasty surgery will be followed.One of these questionnaires is called: KOOS. KOOS is the 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.
Measured: 1 year
Coronal plane angles
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ligament; Laxity, KneeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective, single-group, non-blind, interventional study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Lars Engseth, Oslo University Hospital
- Investigators
- Lars HW Engseth, MD, Principal investigator, Oslo University Hospital, Ullevaal, Oslo, NorwayJarle Vik, MD, Principal investigator, Baerum Hospital, Vestre Viken Hospital Trust, Baerum, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264076
- Sponsor's protocol ID
- 686340
- Other IDs
- CIV-NO-23-09-043976
- Acronym
- BLIS-TKA
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, due to national data protection laws.
Publications
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.
PubMed 19290507Bellemans J. Multiple needle puncturing: balancing the varus knee. Orthopedics. 2011 Sep 9;34(9):e510-2. doi: 10.3928/01477447-20110714-48.
PubMed 21902147Bellemans 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.
PubMed 20452181Aunan 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.
PubMed 22581351Neogi 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.
PubMed 23973124Beswick 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.
PubMed 22357571Aunan 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.
PubMed 29883259Whiteside LA. Soft tissue balancing: the knee. J Arthroplasty. 2002 Jun;17(4 Suppl 1):23-7. doi: 10.1054/arth.2002.33264.
PubMed 12068398Fang 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.
PubMed 19553073Abdel 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.
PubMed 29557863Magnussen 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.
PubMed 21789710Babazadeh 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.
PubMed 21808688Mihalko 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.
PubMed 14652405Robinson 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.
PubMed 15797588Koh 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.
PubMed 24360488
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique
- ClinicalTrials.gov ID
- NCT06264076
- Acronym / sponsor ID
- BLIS-TKA / 686340
- Conditions
- Ligament; Laxity, Knee, Knee Osteoarthritis
- Keywords
- Total knee arthroplasty (TKA), Total Knee Replacement (TKR), Knee kinematics, Ligament balance, Bellemans, Soft-tissue balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-group, non-blind, interventional study
| Arm | Type | Receives |
|---|---|---|
| Single interventional group at Bærum Hopsital Vestre Viken Hospital Trust | Experimental | Device: A novel instrument for ligament balancing in total knee arthroplastyPatients 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 |
| Single interventional group at OUH Ullevål Hospital | Experimental | Device: Novel Instrument for ligament balancing in knee arthroplastySingel group non-blin interventional study group receiving ligament balancing performed using a novel instrument. Ligament balancing will be evaluated using conventional instruments. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Age under 40 years of age
- Pregnant
- Revisions or reoperations
- Considerable earlier injury to the knee
- Isolated patellofemoral osteoarthrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel instrument for ligament balancing in total knee arthroplastyPatients 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. | Device | Single interventional group at Bærum Hopsital Vestre Viken Hospital Trust |
| Novel Instrument for ligament balancing in knee arthroplastyPatients 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. | Device | Single interventional group at OUH Ullevål Hospital |
Primary outcome
Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
Time frame: 1 year
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.
MCL-lengthening in millimeters after ligament balancing using the novel instrument
Time frame: 1 year
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.
9 secondary outcomes
Demographic information - height (cm) - and how this parameters affects ligament balancing.
Time frame: 1 year
Demographic information - weight (kg) - and how this parameters affects ligament balancing.
Time frame: 1 year
Demographic information - age (years) - and how this parameters affects ligament balancing.
Time frame: 1 year
Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.
Time frame: 1 year
Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.
Time frame: 1 year
Patient reported outcome measures (PROM) using EQ-5D-5L
Time frame: 1 year
Patient reported outcome measures (PROM) using FJS-12
Time frame: 1 year
Patient reported outcome measures (PROM) using KOOS
Time frame: 1 year
Coronal plane angles
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 19290507Verdonk 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.
- Background: PubMed 21902147Bellemans J. Multiple needle puncturing: balancing the varus knee. Orthopedics. 2011 Sep 9;34(9):e510-2. doi: 10.3928/01477447-20110714-48.
- Background: PubMed 20452181Bellemans 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.
- Background: PubMed 22581351Aunan 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.
- Background: PubMed 23973124Neogi 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.
- Background: PubMed 22357571Beswick 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.
- Background: PubMed 29883259Aunan 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.
- Background: PubMed 12068398Whiteside LA. Soft tissue balancing: the knee. J Arthroplasty. 2002 Jun;17(4 Suppl 1):23-7. doi: 10.1054/arth.2002.33264.
- Background: PubMed 19553073Fang 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.
- Background: PubMed 29557863Abdel 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.
- Background: PubMed 21789710Magnussen 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.
- Background: PubMed 21808688Babazadeh 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.
- National Joint RegistryLink provided by the sponsor.
- The American Joint Replacement Registry Annual Report. American Academy of Orthopaedic Surgeons.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No, due to national data protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars HW Engseth, MD principal investigator
Oslo University Hospital, Ullevaal, Oslo, Norway
Jarle Vik, MD principal investigator
Baerum Hospital, Vestre Viken Hospital Trust, Baerum, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel instrument for ligament balancing in total knee arthroplasty and Novel Instrument for ligament balancing in knee arthroplasty in people with Ligament; Laxity, Knee and Knee Osteoarthritis, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars HW Engseth, MD (004741254136, laengs@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264076, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.