Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001662459
Ethics application status
Approved
Date submitted
17/10/2016
Date registered
2/12/2016
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
In patients with osteoarthritis that will undergo high tibial osteotomy, does the use of two different techniques produce the same change their gait mechanics?
Scientific title
In individuals undergoing high tibial osteotomy for osteoarthritis does computer navigated lateral closing wedge high tibial osteotomy or medial opening wedge high tibial osteotomy improve gait mechanics?
Secondary ID [1] 290341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HTO MO v LC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 300613 0
Condition category
Condition code
Musculoskeletal 300462 300462 0 0
Osteoarthritis
Surgery 300463 300463 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In patients with symptomatic medial compartment (inner side), knee osteoarthritis (OA) and associated genu varum (bowing of the lower limb) performing a high tibial osteotomy (HTO) can provide pain relief by changing the shape of the limb. The shape changes the point at which compressive load crosses the knee. This unloads the painful arthritic side of the knee and transfer load to the undamaged lateral compartment (outside)of the knee. There are two widely used HTO techniques. These are the medial opening wedge (MO) and the lateral closing wedge (LC) HTO. Intraoperative computer navigation can increase the accuracy and precision of the intended correction but has not been used for the LC technique. It is unclear in the literature, which approach yields the highest patient satisfaction as very few studies have been done that compare the two techniques. Additionally, there are even fewer studies that have examined the changes to gait mechanics that take effect as a result of the described procedures. To detect a difference between the two procedures, patients will undergo preoperative and postoperative radiographic (x-ray) and functional joint assessments. In addition, investigators will assess changes to the patients' gait by performing analysis at a Gait Laboratory.

Aims and Hypothesis:
1) That the same correction achieved intraoperatively using two different osteotomy techniques will produce the same correction to standing limb shape and gait mechanics
2) Computer navigated LC wedge is as accurate as computer navigated MO wedge HTO.

Research Design:
The design of this project is a single centre, multi-surgeon, prospective, randomised controlled trial. (Evidence Level II)

Materials and Methods:
Patients planned to undergo a HTO procedure at the investigators' clinic who fit study inclusion criteria, may be approached to voluntarily participate in the study. Patients will be randomised to the MO wedge HTO group or LC wedge HTO group at time of consent. Alignment corrections associated with the procedure will be standardised to 3.5 degrees of valgus. Patients will undergo assessments preoperatively, and postoperatively for followup in clinic at six weeks, six months and yearly.The intervention/procedure that will be performed is called a high tibial osteotomy (HTO). The operation involves changing the shape of the tibia (shin bone) by performing a bone cut (osteotomy) that does not completely finish and then separating the edges with a hinge at one end. The change in shape of the tibia results in changing the way force is transmitted through the knee joint. This accuracy and precision of this surgery is increased by the use of a computer navigation system. The corrections are held in place using a plate and screw fixation device.

Arm 1: Medial Opening Wedge (MO) High Tibial Osteotomy. This procedure makes the aforementioned osteotomy on the medial side (inside edge) of the tibia and separates the edges from each other thus "opening" a wedge of bone. This is the commonest procedure done and will act as the control.

Arm 2: Lateral Closing Wedge (LC) Hight Tibial Osteotomy: This procedure makes two cuts and removes a wedge of bone from the lateral side (outside edge) of the tibia and then the two ends are brought closer together.

The surgical time for each procedure varies, both procedures take similar time from start (knife to skin) to completion (surgical wound closure). Both procedures can take from 45 minutes up to 1 hour each to complete.
Intervention code [1] 296152 0
Treatment: Surgery
Comparator / control treatment
The control is as described in Arm 1 above of the interventions/exposures. It is an intervention.
Control group
Active

Outcomes
Primary outcome [1] 299900 0
Gait analysis
Each patient will have gait analysis preoperatively to create a baseline (whereby we compare the preoperative Gait to postoperative gait). To analyse gait, the investigators must quantify the moments of force for adduction, abduction and ground reaction during the patients walking pattern. Trackers are placed on specific 'markers' on the body to measure the feedback movement and force as the patient walks down a path fitted with sensor detectors. This is then repeated 6 months post-operatively when patients have been off crutches for some time and have completed the majority of rehabilitation and thus should be walking close as "normal".
Timepoint [1] 299900 0
Preoperatively and 6 months postoperatively.
Secondary outcome [1] 328443 0
Range of Movement- measured using a digital inclinometer
Timepoint [1] 328443 0
Preoperatively, 6 weeks postoperatively, 6 months postoperatively and 12 months postoperatively
Secondary outcome [2] 328444 0
Time to weight bear, as defined as time in days postoperatively when the patient is able to full weight bear on the operative limb.
Assessment will be carried out at 6 week mark in clinic, also self-reported by patient at anytime outside of the scheduled visits as part of routine care and research protocol.
Timepoint [2] 328444 0
Time point will be assessed after 6 weeks postoperatively as this is likely to be the minimum time to full weight bearing
Secondary outcome [3] 328446 0
Time to weight bear without crutches- as defined as time in days to which point the patient is steady to walk without crutches as deemed by physiotherapist or surgeon
Timepoint [3] 328446 0
Will be assessed at least 6 weeks postoperatively as this is the minimum time likely needed to reach this end point. This will be self reported but assessed by surgeon or physiotherapist.
The patient will return at the 6 month postoperative time point where by self assessment will report walking free with absence of crutches.
Secondary outcome [4] 328447 0
scar size, measured in centimeters. This is the length of the scar for any screw and plate insertion. This does not include scars of any arthroscopy that may be done for computer navigation
Timepoint [4] 328447 0
immediately post-operatively
Secondary outcome [5] 328449 0
Radiological Outcomes: Hip Knee Ankle Angle- from long leg weight-bearing anteroposterior radiographs. Measured as the angle subtended by a line through the centre of the head of femur to the highest point in the distal femoral intercondylar notch and a line between the spines of the tibia and midpoint of the talus. (See study protocol attached to ANZCTR form for clarification)
Timepoint [5] 328449 0
Preoperatively and 6 months postoperatively
Secondary outcome [6] 328450 0
Radiological Outcomes: Posterior tibial slope- measured by an angle that subtends a line drawn vertically from the posterior edge of the tibial shaft to the tibial plateau, performed by X-ray.
Timepoint [6] 328450 0
Preoperatively, 6 and 12 months posteroperatively
Secondary outcome [7] 328451 0
Radiologial Outcome: Patellar height- as calculated using the Blackburne-Peele method, The imaging will be performed by X-ray.
Timepoint [7] 328451 0
Preoperatively, 6 and 12 months postoperatively
Secondary outcome [8] 328453 0
Radiological Outcome (performed by X-ray): Time to union- as defined as the time in days at which there is an absence of pain upon local palpation, an absence of swelling in the limb, an ability to talk painlessly without crutches, and an evidence of radiographic bridging callus or trabecula between fragments
Timepoint [8] 328453 0
Time measured after 6 weeks on plain radiograph as seen by consultant surgeons
Secondary outcome [9] 328454 0
Patient Reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [9] 328454 0
Preoperatively, 6 weeks postoperatively, 6 months postoperatively and 12 months postoperatively
Secondary outcome [10] 328455 0
Patient Reported Outcome Measures: Oxford Knee Score (OKS)
Timepoint [10] 328455 0
Preoperatively, 6 weeks postoperatively, 6 months postoperatively and 12 months postoperatively
Secondary outcome [11] 328456 0
Visual Analogue Scale (VAS) pain score
Timepoint [11] 328456 0
Preoperatively, 6 weeks postoperatively, 6 months postoperatively and 12 months postoperatively

Eligibility
Key inclusion criteria
Age 30–60 years
Body Mass Index less than 35
Medial compartment Osteoarthritis with medial knee pain
Intact Anterior Cruciate Ligament
Varus malalignment of less than 10 degrees
Normal lateral compartment
Clinically silent patellofemoral compartment
Fixed Flexion Deformity less than 10 degrees
Flexion Range of Movement greater than 110 degrees
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Osteoarthritis of the lateral compartment
Symptomatic osteoarthritis of the patellofemoral joint
Rheumatoid arthritis
Previous infection in the knee
History of an angulated fracture of the lower extremity
Fixed Flexion Deformity of greater than 10 degrees

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given there is no previous study that has looked at navigated HTOs, or any surrogate that we can use to perform sample size calculation, we will initially recruit 10 patients to each arm of the study, and perform interim calculations for statistical difference, if this is insufficient we will recruit a further 10 patients to each arm of the study, giving us a total of 40 patients in the complete study

Statistical analysis will be performed by an independent statistician experienced in biomechanics. The data will be cleared of personal identifiers such as name and hospital reference numbers and sent as raw data to be analyzed. Data will be analysed for normality using the Kolmogorov-Smirnov method, and then either parametric or non-paramentric tests will be applied. Gait analysis data will be compared to normative data that exists in published literature. Numerical data such as ROM, time to weight bear, HKA angle, posterior tibial slope, patellar and scar size will be assesed using repeated measures ANOVA testing. PROM data will be compared using Spearman's Rank Correlation.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
1/03/2019
Actual
Date of last data collection
Anticipated
3/03/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6829 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 14494 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 294726 0
Government body
Name [1] 294726 0
Queensland Health
Country [1] 294726 0
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] 293569 0
None
Name [1] 293569 0
Address [1] 293569 0
Country [1] 293569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296144 0
Mater Hospital Pimlico Human Research Ethics Committee
Ethics committee address [1] 296144 0
Chairperson
Human Research Ethics Committee
Mater Health Services North Queensland Ltd
21-29 Fulham Rd
Pimlico, Townsville, QLD 4812.
Ethics committee country [1] 296144 0
Australia
Date submitted for ethics approval [1] 296144 0
10/10/2016
Approval date [1] 296144 0
14/12/2016
Ethics approval number [1] 296144 0
MHS20161122-02

Summary
Brief summary
In patients with symptomatic medial compartment (inner side), knee osteoarthritis (OA) and associated genu varum (bowing of the lower limb) performing a high tibial osteotomy (HTO) can provide pain relief by changing the shape of the limb. The shape changes the point at which compressive load crosses the knee. This unloads the painful arthritic side of the knee and transfer load to the undamaged lateral compartment (outside)of the knee. There are two widely used HTO techniques. These are the medial opening wedge (MO) and the lateral closing wedge (LC) HTO. Intraoperative computer navigation can increase the accuracy and precision of the intended correction but has not been used for the LC technique. It is unclear in the literature, which approach yields the highest patient satisfaction as very few studies have been done that compare the two techniques. Additionally, there are even fewer studies that have examined the changes to gait mechanics that take effect as a result of the described procedures. To detect a difference between the two procedures, patients will undergo preoperative and postoperative radiographic (x-ray) and functional joint assessments. In addition, investigators will assess changes to the patients' gait by performing analysis at a Gait Laboratory.

Aims and Hypothesis:
1) That the same correction achieved intraoperatively using two different osteotomy techniques will produce the same correction to standing limb shape and gait mechanics
2) Computer navigated LC wedge is as accurate as computer navigated MO wedge HTO.

Research Design:
The design of this project is a single centre, multi-surgeon, prospective, randomised controlled trial. (Evidence Level II)

Materials and Methods:
Patients planned to undergo a HTO procedure at the investigators' clinic who fit study inclusion criteria, may be approached to voluntarily participate in the study. Patients will be randomised to the MO wedge HTO group or LC wedge HTO group at time of consent. Alignment corrections associated with the procedure will be standardised to 3.5 degrees of valgus. Patients will undergo assessments preoperatively, and postoperatively for followup in clinic at six weeks, six months and yearly.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1178 1178 0 0
/AnzctrAttachments/371511-Ammended Study Protocol Nav MOvLC Version 2.2 update 15092016.docx (Protocol)
Attachments [2] 1179 1179 0 0
/AnzctrAttachments/371511-Ammended FORCE Master Participant Information Form version 1.2 Nav HTO MOvLC update 15092016 AG.docx (Participant information/consent)
Attachments [3] 1180 1180 0 0
/AnzctrAttachments/371511-Ammended FORCE Master Consent FORM Nav HTO MO v LC updated 15092016.docx (Participant information/consent)
Attachments [4] 1181 1181 0 0
/AnzctrAttachments/371511-NEAF 15092016 AU1EAD827.pdf (Other)

Contacts
Principal investigator
Name 69102 0
Dr Peter McEwen
Address 69102 0
North Queensland Knee, Orthopaedic Research Institute of Queensland (ORIQL)
Suite 3, Level 2, Mater Medical Centre 21-29 Fulham Rd, Pimlico, QLD 4812
Country 69102 0
Australia
Phone 69102 0
+61747794788
Fax 69102 0
Email 69102 0
[email protected]
Contact person for public queries
Name 69103 0
Mrs Andrea Grant
Address 69103 0
The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, QLD 4812
Country 69103 0
Australia
Phone 69103 0
+61747550564
Fax 69103 0
Email 69103 0
[email protected]
Contact person for scientific queries
Name 69104 0
Mrs Andrea Grant
Address 69104 0
The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, QLD 4812
Country 69104 0
Australia
Phone 69104 0
+61747550564
Fax 69104 0
Email 69104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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
No additional documents have been identified.