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Trial registered on ANZCTR

Registration number

ACTRN12616001706460

Ethics application status

Approved

Date submitted

17/10/2016

Date registered

13/12/2016

Date last updated

16/07/2021

Date data sharing statement initially provided

27/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

In individuals undergoing simultaneous bilateral total knee replacement, does making a lateral skin incision affect skin sensation, ability to kneel and patient satisfaction?

Scientific title

In individuals undergoing simultaneous bilateral total knee replacement, does making a lateral skin incision affect skin sensation, ability to kneel and patient satisfaction.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Total knee arthroplasty

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will undergo a total knee replacement in both knees to treat osteoarthritis. Two different skin incisions will be used. The study exposure called the lateral incision. It is an incision that starts 5cm midline above the patella (knee cap) and as is curved inferiorly (down the knee) and laterally (the outer side edge) around the patella. It finishes curving back once passed the patella towards the midline of the tibia (shin). (Please see study protocol attached to ANZCTR registration form for images.) We hypothesize that the more lateral or towards the outside of the knee the incision is, the less insensate skin on the outer side of the knee will be and the patient will be able to kneel better. The lateral skin incision will be performed with a scalpel. Deeper dissection will be performed with diathermy cautery. Skin flaps will be mobilised. A midvastus medial parapatellar arthrotomy will be done and the knee joint exposed with the patella flipped laterally Computer navigation will be used. The surgery will take 60-90 minutes.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Patients will undergo a total knee replacement in both knees to treat osteoarthritis. Two different skin incisions will be used, the control group will be the opposite knee with an incision centred in the middle of the knee . Computer navigation will be used. The surgery will take 60-90 minutes.

Control group

Active

Outcomes

Primary outcome [1]

Skin sensation to knee area as measured by pin prick testing and area drawn on skin. Photo of area will be taken with scale included in the image. Area will be measured using a open source image analysis software using the scale to calibrate the area.

Timepoint [1]

6 months post-operatively, 12 months post-operatively

Primary outcome [2]

Kneeling ability- graded using a novel grading system for each knee, defined as able to get to grading position and then get to standing position. Grading is as follows
Grade 1) Partial squat (knee flexes above 90 degrees)
Grade 2) Full squat (knee flexes down past 90 degrees)
Grade 3) Split kneel (study knee on floor flexed to 90 degrees and contralateral knee flexed to 90 degrees with foot on floor)
Grade 4) 90 degrees kneel (both knees flexed to 90 degrees on the floor
Grade 5) Full kneel (both knees on floor, knees flexed past 90 degrees, sitting back on haunches)

Timepoint [2]

Baseline (pre-operatively), 6 weeks post-operatively, 12 months post-operatively

Primary outcome [3]

Pain relief requirement, graded using the grades:
1) None - nil/ice pack/heat pack
2) Mild - occasional NSAID use
3) Moderate - Regular NSAID use
4) Severe - Regular NSAID use + breakthrough occasional opiate use
5) Very Severe - Regular NSAID use + Opiate Use

Timepoint [3]

6 months post-operatively, 12 months post-operatively

Secondary outcome [1]

Range of motion (limits of flexion and extension as a composite outcome), as assessed by the surgeon using a digital inclinometer,

Timepoint [1]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [2]

Length of scar in centimetres

Timepoint [2]

6 months post-operatively, 12 months post-operatively

Secondary outcome [3]

KOOS - junior (Validated outcome score)

Timepoint [3]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [4]

Oxford Knee Score (Validated outcome score)

Timepoint [4]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [5]

Visual-analogue scale pain score (Validated outcome score)

Timepoint [5]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [6]

Kujala Anterior Knee Pain score (Validated outcome score)

Timepoint [6]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [7]

Forgotten Joint Score (Validated Outcome Score)

Timepoint [7]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [8]

5Q-5D (Validated Outcome score)

Timepoint [8]

Baseline (Pre-operative), 6 months post-operatively, 12 months post-operatively

Secondary outcome [9]

Composite Outcomes collected using Computer assisted surgery data recorded from the Navigation system during the surgery.
1. Navigated alignment
2. Tibial slope
3. Degree of flexion and extension
4. Tibial and femoral cuts
5. Medial and lateral flexion and extension gaps
6. Varus/valgus alignment
7. Internal/external rotation
8. Size of tibial and femoral implant

Timepoint [9]

Data will be collected using Navigation intraoperatively

Eligibility

Key inclusion criteria

Patients scheduled to undergo bilateral knee arthroplasty
Male and female
Age 40-90
Able to provide informed consent

Minimum age

40 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Conditions causing altered sensation up to knee- Diabetic Neuropathy, regional pain syndrome
Previous open surgical procedure to knee
Patients with inflammatory arthritis
Patients not suitable for patella resurfacing

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

We will generate a random sequence of numbers using an online random number generator. This sequence will be used to allocate participants to a study group.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

We will de-identify data and send it to an external statistician to perform the appropriate statistical testing. To perform a sample size calculation, we used a study by Borely et al. The expected surface area of loss of skin innervation in midline skin incisions in TKA was found to be of mean of 66cm2 with a standard deviation (SD) of 30 cm2. As there is are no published observational data for lateral skin incisions, we assumed the loss of skin sensation of 44cm2 with same SD of 30 cm2 with lateral skin incisions. Assuming Type I error (alpha) to 5% (p = 0.05) and Type II error (beta) to 0.2 (power equal to 80%), the sample size calculated was 30 knees in each group, therefore 60 knees. We will investigate 66 knees to compensate for 10% expected loss to follow-up. As we are using bilateral knees, we will need 33 patients.

We will use SPSS software to analyse the data. For the continuous data such as the area of reduced sensation will use repeated measures ANOVA. The difference in the means of the PROMs data, as well as the kneeling grade will determined using the non-parametric Wilcoxon’s signed- rank test for non-normally distributed data, an unpaired t-test for normally distributed data.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2017

Actual

19/06/2017

Date of last participant enrolment

Anticipated

30/12/2018

Actual

21/03/2019

Date of last data collection

Anticipated

31/03/2020

Actual

21/03/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4810 - Pimlico

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The Orthopaedic Research Institute of Queensland

Address [1]

7 Turner St, Pimlico, QLD 4812

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

The Orthopaedic Research Institute of Queensland (ORIQL

Address

7 Turner St, Pimlico, QLD 4812

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Hospital Pimlico Human Research Ethics Committee

Ethics committee address [1]

Chairperson
Human Research Ethics Committee
Mater Health Services North Queensland Ltd
21-29 Fulham Rd,
Pimlico, Townsville QLD 4812

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2016

Approval date [1]

14/12/2016

Ethics approval number [1]

MHS20161122-01

Summary

Brief summary

The initial skin incision performed to expose the knee during total knee arthroplasty (TKA) is centred over the patella for ease of access to the joint. This places the scar directly over the bony points of the knee that bear load when kneeling, leaving the skin on the lateral side (outside) of the scar with reduced sensation and sometimes the skin on the medial side (inside) of the scar with painfully altered sensation (dysaesthesiae / neuromata). Placing the skin incision lateral to the edge of the patella (kneecap) avoids the necessity of kneeling on a scar and has been shown to reduced dysaesthesiae and neuromata in other knee procedures. 

Primary Aim:  
To prove that lateral skin incisions improve the ability to kneel in patients following bilateral total knee arthroplasty

Secondary Aim: 
1.Investigate whether lateral skin incision has improved retention of skin sensation.
2.Investigate the ability to kneel after TKA.
3.Investigate if there is improved deep flexion.
4.Investigate whether there is decreased pain and better satisfaction as per patient reported outcome measures (PROM)

Research Design:
Prospective, Randomized Controlled Trial.

Patient Demographic:  Eligible patients aged between 40-90 years of age with bilateral, tri-compartmental osteoarthritis (OA),undergoing simultaneous bilateral TKA.  Patients with previous knee arthrotomy (cut to the joint capsule) will be excluded. 

Patients' limbs will be randomized for surgery into two groups; (1) Midline Incision Group and (2) Lateral Incision Group.  

Outcomes:measured at, six months, and 12 months post-operatively.
- Knee flexion and extension.
- Kneeling Grade Assessment- a novel grading system has been developed that Grades the ability to kneel from 1-5 depending on how far down the patient can knee.
- Area of skin dysaesthesia (uncomfortable change in skin sensation) will be mapped and analyzed using imaging software.
- Neuroma formation.
- PROMs (patient reported outcome measures).

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/371143-Study Protocol Lateral skin incision v2.3 update 21072016.docx (Protocol)

Attachments [2]

/AnzctrAttachments/371143-Participant Information Form Lateral Incision version 1.1 updated 21072016.docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Peter McEwen

Address

North Queensland Knee, Orthopaedic Research Institute of Queensland (ORIQL)
Suite 3, Level 2, Mater Medical Centre 21-29 Fulham Rd, Pimlico, QLD 4812

Country

Australia

Phone

+61747794788

Fax

peter@kneesurgeon.com.au

Contact person for public queries

Name

Andrea Grant

Address

The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, QLD 4812

Country

Australia

Phone

+61747550564

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Andrea Grant

Address

The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, QLD 4812

Country

Australia

Phone

+61747550564

Fax

research_coordinator@oriql.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

All data will remain in a private database, in a de-identified but re-identifiable format.

We have not yet worked out a platform on which to share the data, or the appropriate data to be shared. Our research group is currently in the in the process of coming to an agreement on this.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Skin sensory alteration and kneeling ability following cruciate retaining total knee arthroplasty are not affected by the incision position: A randomised controlled trial of simultaneous bilateral surgery.	2023	https://dx.doi.org/10.1186/s40634-023-00695-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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