Clinical trial NCT06921889: The Biomechanical Outcomes of Autologous Chondrocyte Implantation
Official title: Investigating the Biomechanical and Functional Outcomes of Autologous Chondrocyte Implantation: A Multi-centre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chondral Defect
Keywords: Chondral defect
Cartilage repair
Knee
Autologous chondrocyte implantation
Biomechanical outcome
Gait
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants undergoing ACI surgery for a chondral lesion in the knee.

Brief summary: 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.

Detailed description: Knee joint articular cartilage is a primary load-bearing surface that endures repetitive high impact loading during activities of daily living. Individuals of any age can injure the knee's articular cartilage. However, as cartilage has an innate limited capacity to regenerate, surgical interventions that adopt tissue engineering techniques are often necessary to repair cartilage and preserve the joint.

Autologous chondrocyte implantation (ACI) is a surgical procedure that is offered to some patients with focal cartilage injuries of the knee. The first pilot study on the use of ACI in humans was published by Brittberg and colleagues in 1994. By 2010 35,000 ACI procedures had been performed worldwide.

Patient-reported outcomes and survivorship of ACI have been well reported in current literature. However, objective biomechanical and functional outcomes of ACI patients are not well understood. This knowledge is essential for optimising treatment, because poor functional outcome is known to worsen quality of life. This is particularly true for patients of working age who wish to return to an active and independent lifestyle.

The applicant recently conducted and published a systematic review on the functional outcome of ACI. The review identified only 19 eligible articles of 20 ACI cohorts. The data showed that the average range of motion (ROM) improved with clinical (\>5˚) and statistical significance (p \< 0.05) postoperatively: 130.5± 14.8˚ to 136.1±10.2º, however only 7 studies reported both pre- and post-operative RoM. Knee strength significantly improved within the first two postoperative years but remained poorer than control groups at final follow-up (n=11). The review also found no statistical differences between ACI and control groups in their ability to perform functional activities like the 6-minute walk and hop tests post-operatively (n = 8). Only two papers had published on the kinematics of gait post-operatively. Both papers reported the outcomes of the same cohort, stating that there were no significant differences in spatio-temporal parameters between ACI patients and controls post-operatively. However, kinematic differences were observed during two specific phases of the gait cycle. Differences were also reported in peak knee adduction and peak knee extension moments.

The limited literature identified by this review highlighted the urgent need for research into the functional outcomes of joint preservation surgeries like ACI to optimise functional outcome.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knee range of motion measured in degrees with a goniometer
timeFrame: 6 months
Secondary outcomes:
measure: Gait kinematics measured by motion capture technology
timeFrame: 6 months
measure: Gait kinetics measured by motion capture technology
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leeds
country: United Kingdom
facility: Chapel Allerton Orthopaedic Centre
city: Manchester
country: United Kingdom
facility: Trafford General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: University of Manchester
name: Gwenllian F Tawy, PhD
role: PRINCIPAL_INVESTIGATOR
References: