Chondral DefectNCT06921889
The Biomechanical Outcomes of Autologous Chondrocyte Implantation
An observational study of Chondral Defect, run by University of Manchester at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondral Defect
- What is being tested?
- Autologous Chondrocyte Implantation (ACI)
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 22 Apr 2024to 13 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants undergoing ACI surgery for a chondral lesion in the knee.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites, 7 recruiting
- Not yet recruiting
Royal Orthopaedic Hospital
Birmingham, B31 2AP
Martyn Snow, FRCS
Martyn Snow, FRCS
- Not yet recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Wasim Khan, FRCS
Wasim Khan, FRCS
- Recruiting
Chapel Allerton Orthopaedic Centre
Leeds, LS7 4SA
Ram Venkatesh, FRCS
Ram Venkatesh, FRCS
- Recruiting
Trafford General Hospital
Manchester, M415SL
Gwenllian F Tawy, PhD
Leela Biant
- Not yet recruiting
Southampton General Hospital
Southampton, SO16 6YD
Gorav Datta, FRCS
Gorav Datta, FRCS
- Recruiting
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
Chethan Jayadev, FRCS
Chethan Jayadev, FRCS
- Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
Varun Dewan, FRCS
Varun Dewan, FRCS
About this study
Official title: Investigating the Biomechanical and Functional Outcomes of Autologous Chondrocyte Implantation: A Multi-centre Study
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.
Read more
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.
Read the 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.
- Conditions
- Chondral Defect
- Being tested
- Autologous Chondrocyte Implantation (ACI)
- Keywords
- Chondral defect, Cartilage repair, Knee, Autologous chondrocyte implantation, Biomechanical outcome, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Chondrocyte Implantation (ACI)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Study Participant | All participants of this study will be undergoing an autologous chondrocyte implantation of the knee for a chondral defect. Receives: Procedure: Autologous Chondrocyte Implantation (ACI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee range of motion measured in degrees with a goniometer
Change in knee range of motion in degrees post-operatively.
Measured: 6 months
Secondary outcomes (2)
Gait kinematics measured by motion capture technology
Changes to gait kinematics (angles in degrees) post-operatively
Measured: 6 months
Gait kinetics measured by motion capture technology
Changes to gait kinetics (force in Newton) post-operatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start22 Apr 2024
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral DefectStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwenllian Tawy, University of Manchester
- Investigators
- Gwenllian F Tawy, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921889
- Sponsor's protocol ID
- v1 04/08/2023
- Status last verified
- May 2026
- First submitted
- 24 Mar 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from this study will be stored by the researchers in the University of Manchester Research Data Storage service for 5 years after publication in line with the University of Manchester Research Data Management Policy. Prior to destruction, the non-identifiable (anonymised) electronic data from the study (including IPD) will be archived on Figshare then securely deleted from the University of Manchester Research Data Storage service. Figshare is the University's recommended repository.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Biomechanical and Functional Outcomes of Autologous Chondrocyte Implantation: A Multi-centre Study
- ClinicalTrials.gov ID
- NCT06921889
- Acronym / sponsor ID
- v1 04/08/2023
- Conditions
- Chondral Defect
- Keywords
- Chondral defect, Cartilage repair, Knee, Autologous chondrocyte implantation, Biomechanical outcome, Gait
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participant | – | Procedure: Autologous Chondrocyte Implantation (ACI)All participants of this study will be undergoing an autologous chondrocyte implantation of the knee for a chondral defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing ACI surgery for a chondral lesion in the knee.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Chondrocyte Implantation (ACI)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. | Procedure or surgery | Study Participant |
Primary outcome
Knee range of motion measured in degrees with a goniometer
Time frame: 6 months
Change in knee range of motion in degrees post-operatively.
2 secondary outcomes
Gait kinematics measured by motion capture technology
Time frame: 6 months
Gait kinetics measured by motion capture technology
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. The data from this study will be stored by the researchers in the University of Manchester Research Data Storage service for 5 years after publication in line with the University of Manchester Research Data Management Policy. Prior to destruction, the non-identifiable (anonymised) electronic data from the study (including IPD) will be archived on Figshare then securely deleted from the University of Manchester Research Data Storage service. Figshare is the University's recommended repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwenllian F Tawy, PhD principal investigator
University of Manchester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chondral Defect, run by University of Manchester at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwenllian F Tawy, PhD (01617462371, gwenllian.tawy@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee range of motion measured in degrees with a goniometer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.