The Biomechanical Outcomes of Autologous Chondrocyte Implantation

NCT06921889 | Recruiting

• 1 other identifier: v1 04/08/2023
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 7

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.

Conditions

Chondral Defect

Keywords

Chondral defect; Cartilage repair; Knee; Autologous chondrocyte implantation; Biomechanical outcome; Gait

Outcome Measures

Primary Outcomes (1)

• Knee range of motion measured in degrees with a goniometer

  Change in knee range of motion in degrees post-operatively.

  6 months

Secondary Outcomes (2)

• Gait kinematics measured by motion capture technology

  6 months

• Gait kinetics measured by motion capture technology

  6 months

Study Arms (1)

Study Participant

All participants of this study will be undergoing an autologous chondrocyte implantation of the knee for a chondral defect.

Procedure: Autologous Chondrocyte Implantation (ACI)

Interventions

Autologous Chondrocyte Implantation (ACI) PROCEDURE

ACI 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.

Study Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants undergoing ACI surgery for a chondral lesion in the knee.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (7)

Royal Orthopaedic Hospital

Birmingham, B31 2AP, United Kingdom

NOT YET RECRUITING

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Chapel Allerton Orthopaedic Centre

Leeds, LS7 4SA, United Kingdom

RECRUITING

Trafford General Hospital

Manchester, M415SL, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Study Officials

• Gwenllian F Tawy, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwenllian F Tawy, PhD

CONTACT

01617462371; gwenllian.tawy@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 10, 2025
• Study Start: April 22, 2024
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)