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In patients with osteoarthritis that will undergo high tibial osteotomy, does the use of two different techniques produce the same change their gait mechanics?

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?

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001662459
Acronym
HTO MO v LC
Enrollment
20
Registered
2016-12-02
Start date
2018-03-01
Completion date
2019-03-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 med

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.

Sponsors

The Orthopaedic Research Institute of Queensland (ORIQL)
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026