Origin Knee
Research type
Research Study
Full title
The Origin Study: A randomised control trial comparing functional recovery after custom or standard total knee replacement
IRAS ID
268866
Contact name
Adam Jones
Contact email
Sponsor organisation
Wrightington, Wigan and Leigh NHS Trust
ISRCTN Number
91044823
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
Knee osteoarthritis (OA) is a common degenerative process. Knee OA often results in joint pain, stiffness and in turn restricted movement. When more conservative treatment methods fail, patients often elect to undergo a total knee replacement (TKR). While TKR has relatively good outcomes and high patient satisfaction, up to 25% of patients are still dissatisfied after the procedure, with patients often reporting they do not walk ‘normally’ after their operation.
As such there has been continued evolution of implant design to attempt to address these issues. One such development is the introduction of truly custom-made implants based on computed tomography (CT) scanning. The purported advantages of such implants are that they are bespoke for each patient to try and recreate the patient’s natural anatomy and restore their function as close to normal as possible. However, to our knowledge, there are no well-designed studies exploring the rate and magnitude of functional recovery between patients who receive standard off-the-shelf and custom TKR.This study will aim to fill this gap by quantifying and comparing functional recovery between patients who receive standard off-the-shelf and custom TKR. Within this randomised control trial, we will match and assign patients to either a custom or standard TKR group and compare their lower limb joint movement, loading and muscle activation patterns during activities of daily living (walking, turning, kneeling, stair ascent and descent, sitting and rising from a seated position). Additionally, we will collect data on age and gender matched controls to enable us to compare the recovery of the two TKR groups to a healthy population. The data generated within the study will enable us to begin to determine the efficacy of custom TKR to restore joint function and whether custom implants enable faster or greater recovery of movement patterns and loading.
Summary of Results
Total Knee Replacement (TKR) has good outcomes and high patient satisfaction. However, up to 25% of patients are dissatisfied after TKR and patients do not always walk ‘normally’ after their operation. There is therefore a continued evolution of implant design to attempt to address these issues.This project looked at how people recover after having a total knee replacement (TKR), comparing two types of implants: a standard off-the-shelf version and a custom-made version designed to better match each patient’s anatomy. The study also compared these patients to healthy individuals who hadn’t had knee surgery.
The main goal was to find out if recovery differs between people who get a standard knee replacement and those who get a custom one?
To answer this we measured how patients moved and loaded their joints before surgery, and again at 3 and 12 months after surgery. We used a score called the Gait Abnormality Index (GAI) to show how different a person’s walking pattern was compared to healthy people. A lower score meant more normal movement.
People with custom knee replacements showed clear improvements in how they walked at both 3 and 12 months after surgery. People with standard knee replacements did not show significant (important) changes in walking patterns. At 3 months, those with custom implants improved more than those with standard ones. By 12 months, both groups had improved, but the custom group still showed a greater overall change.
Patients also filled out a questionnaire called the Oxford Knee Score (OKS), which measures pain and function. Both groups improved over time, but the custom group started with better scores and continued to improve more between 3 and 12 months.
We also explored how accurately a smartphone application (myrecovery.ai) measured knee movement. We found that the application provided an accurate way of measuring knee movement when compared to our specialised laboratory equipment.
Finally, we also looked to see how reliable different ways of tracking the movement of the body are. We found that a six-degrees-of-freedom model which monitors how each segment of the body moves independently provided a more reliable and likely accurate way of measuring joint movement when compared to another type of model (a conventional gait model).
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0057
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion