About this trial
Injury to the knee can damage the lining of the knee's bones, called cartilage. Cartilage injuries cause pain and limit movement, making activities like walking, playing sports, and working difficult.
Cartilage cannot repair itself well, so surgery is often needed to repair it. People who have cartilage repair surgery want to return to normal activities after their operation. Doctors and scientists know the operation can reduce pain, but do not fully understand how it affects movement.
This research will help us see if knee function gets better after cartilage repair surgery. The results will help doctors and patients understand what to expect from the surgery. It could also uncover common problems after surgery that could be fixed with physiotherapy.
This research is important because untreated cartilage injuries can develop into arthritis later in life. Arthritis is a painful lifelong condition that could be prevented by effectively treating the cartilage injury.
In this study, adult patients who are waiting to have a type of cartilage repair surgery called 'autologous chondrocyte implantation' (ACI) at one of 7 hospitals will be invited to take part in the study by their surgeon. Patients who decide to take part will be invited to two appointments at their own hospital, where assessments of their knee function will be performed. The tests will assess the knee's movement, and the patient's balance and walking abilities. The first research appointment will take place before the operation, and the second and final appointment will take place 6-months after surgery. The results of this study will help us understand how knee function changes after cartilage repair surgery.
The study will take place across 7 ACI centres in England, and is funded by Orthopaedic Research UK and the British Association for Surgery of the Knee.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of a chondral injury to the knee by a consultant orthopaedic surgeon Participants must have this diagnosis, else they are not eligible for ACI surgery.
Listed for ACI for a chondral injury by a consultant orthopaedic surgeon Participants must be listed for ACI, as this is the treatment of interest in this research study
Over 18 years old Participants must be legally capable of providing informed consent for the study.
Disqualifiers
Listed for any treatment other than ACI Participants must be listed for ACI, as this is the treatment of interest in this research study
Under 18 years old. Participants must be legally capable of providing informed consent for the study.
Trial population
Participants undergoing ACI surgery for a chondral lesion in the knee.
Trial design
Cohort
Prospective
Treatments tested in this trial
Autologous Chondrocyte Implantation (ACI)
Procedure/SurgeryACI is a two-stage process that utilises the patient's own chondrocytes to repair damaged chondral tissue. After a harvesting procedure to obtain the cells, the chondrocytes are cultured and expanded in a specialised laboratory. A second procedure is then performed to implant the cells into the defect to replace and regenerate the injured cartilage. ACI allows the knee to generate durable and hyaline-like repair tissue.
Treatment groups
Trial outcomes
Primary outcomes
Knee range of motion measured in degrees with a goniometer
Change in knee range of motion in degrees post-operatively.
Secondary outcomes
Gait kinematics measured by motion capture technology
Changes to gait kinematics (angles in degrees) post-operatively
Gait kinetics measured by motion capture technology
Changes to gait kinetics (force in Newton) post-operatively
Sponsors and contacts
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