Clinical trial NCT06264076: Ligament Balancing in Total Knee Arthroplasty
Official title: Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ligament; Laxity, Knee
Knee Osteoarthritis
Keywords: Total knee arthroplasty (TKA)
Total Knee Replacement (TKR)
Knee kinematics
Ligament balance
Bellemans
Soft-tissue balance
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
First posted: 2024-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-group, non-blind, interventional study
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
timeFrame: 1 year
Secondary outcomes:
measure: MCL-lengthening in millimeters after ligament balancing using the novel instrument
timeFrame: 1 year
measure: Demographic information - height (cm) - and how this parameters affects ligament balancing.
timeFrame: 1 year
measure: Demographic information - weight (kg) - and how this parameters affects ligament balancing.
timeFrame: 1 year
measure: Demographic information - age (years) - and how this parameters affects ligament balancing.
timeFrame: 1 year
measure: Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.
timeFrame: 1 year
measure: Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.
timeFrame: 1 year
measure: Patient reported outcome measures (PROM) using EQ-5D-5L
timeFrame: 1 year
measure: Patient reported outcome measures (PROM) using FJS-12
timeFrame: 1 year
measure: Patient reported outcome measures (PROM) using KOOS-12
timeFrame: 1 year
Other outcomes:
Locations:
city: Bærums Verk
country: Norway
facility: Baerum Hospital, Vestre Viken Hospital Trust
state: Viken
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: Oslo University Hospital, Ullevaal, Oslo, Norway
name: Lars HW Engseth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baerum Hospital, Vestre Viken Hospital Trust, Baerum, Norway
name: Jarle Vik, MD
role: PRINCIPAL_INVESTIGATOR
References:
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