Knee InjuriesNCT06916728
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
An observational study of Knee Injuries and Joint Surface Knee Lesions, run by Smith & Nephew, Inc. at 8 sites in 6 countries.
Trial summary
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Knee Injuries, Joint Surface Knee Lesions
- What is being tested?
- Marketed Product - MP01
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 170 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 5 May 2025to 4 Feb 2030
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 170 subjects who had joint surface lesions of the knee, participated in the pivotal study and consent to continue follow-up will be enrolled.
Who may be able to join
- Participated in the pivotal study.
- Must be physically and mentally willing and able to comply with the follow-up schedule.
- Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
Who cannot join
- Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
- Chemotherapy in the past 12 months.
- Participation in other clinical trials involving knee procedures.
- Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Italy2 sites
Humanitas Gavazzeni
Bergamo, 24125
Istituto Clinico Humanitas
Milan, 20089
Serbia2 sites
Institut za Ortopedsko hiruske Bolesti "Banjica"
Belgrade, 11000
Klinika Orto MD
Novi Sad, 21000
United States1 site
Horizon Clinical Research
La Mesa, California, 91942-3026
Romania1 site
County Hospital Timis Othopedy and Trauma Clinic II
Timișoara, 300736
About this study
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).
Read the detailed description
This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of the knee. Up to 12 sites in the United States (US) and outside of the US (OUS) that participated in the pivotal study "A Prospective Multicenter Open-label Randomized Controlled Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee" (Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. Enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. As randomization was 2:1 in the pivotal study, the expected number of Marketed Product - MP01 and SSOC subjects enrolled into this study are approximately 114 and 56, respectively.
- Conditions
- Knee Injuries, Joint Surface Knee Lesions
- Being tested
- Marketed Product - MP01, Surgical Standard of Care
- Keywords
- Knee cartilage lesions, joint surface lesions of the knee
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Product - MP01Device
Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.
Surgical Standard of CareProcedure or surgery
As no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used.
Deb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defects by creating small holes in the bone beneath the damaged cartilage.
| Study group | Role | What they receive |
|---|---|---|
| Marketed Product - MP01 | Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study. Receives: Device: Marketed Product - MP01 | |
| Surgical Standard of Care - SSOC | Subjects who had joint surface lesions of the knee randomized to be treated with Surgical Standard of Care (SSOC) - microfracture or debridement in the Pivotal study. Receives: Procedure: Surgical Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
Long-term effectiveness of Marketed Product - MP01 compared to SSOC measured by change in baseline to year 7 in overall KOOS (mean of Pain, Symptoms, Quality of Life (QOL), Function in Daily Living (ADL) and Sports subscales) in subjects treated with Marketed Product - MP01 vs SSOC. Baseline is defined as the pivotal study screening visit.
Overall scores are converted to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).
Measured: Baseline and 7 years
Secondary outcomes (11)
Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)
Kaplan-Meier survival estimates will be used to estimate time to secondary invasive intervention (open procedure, mini open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) excluding intra-articular injections.
Measured: up to 10 years
Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections)
Kaplan-Meier survival estimates will be used to estimate time to secondary invasive intervention (open procedure, mini-open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) including intra-articular injections.
Measured: up to 10 years
Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate
Cumulative incidence rate up to 10 years of secondary invasive interventions (open procedure, mini-open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) including intra-articular injections.
Measured: up to 10 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports).
Subscale scores are converted to a 0-100 scale to determine the Overall score, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).
Measured: Baseline and 7 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports).
Subscale scores are converted to a 0-100 scale to determine the Overall score, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).
Measured: Baseline and 10 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Each item has five possible answer options scored from 0 (no problems) to 4 (extreme problems), and each of the five subscales is calculated as the sum of the associated items. Scores are converted to a 0-100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., best outcome).
Measured: Baseline and 7 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Each item has five possible answer options scored from 0 (no problems) to 4 (extreme problems), and each of the five subscales is calculated as the sum of the associated items. Scores are converted to a 0-100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., best outcome).
Measured: Baseline and 10 years
Change from Baseline in Tegner Activity Scale Score at 7 Years
The Tegner Activity Scale assesses the level of work and sports-based activity prior to injury and level of activity post injury that can be documented on a numerical scale. It is a one- item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 indicates the worst outcome while a level of 10 represents the best outcome.
Measured: Baseline and 7 years
Change from Baseline in Tegner Activity Scale Score at 10 Years
The Tegner Activity Scale assesses the level of work and sports-based activity prior to injury and level of activity post injury that can be documented on a numerical scale. It is a one- item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 indicates the worst outcome while a level of 10 represents the best outcome.
Measured: Baseline and 10 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years
The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.
Measured: Baseline and 7 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years
The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.
Measured: Baseline and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start5 May 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion4 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cartiheal (2009) Ltd
- Responsible party
- Sponsor
- Investigators
- Samantha Andrews, Study chair, Smith & Nephew, Inc.Galit Reske, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916728
- Sponsor's protocol ID
- CLN-0029-1272
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
- ClinicalTrials.gov ID
- NCT06916728
- Acronym / sponsor ID
- CLN-0029-1272
- Conditions
- Knee Injuries, Joint Surface Knee Lesions
- Keywords
- Knee cartilage lesions, joint surface lesions of the knee
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cartiheal (2009) Ltd
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 4 Feb 2030 (estimated)
- First posted
- 8 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.
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).
Detailed description
This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of the knee. Up to 12 sites in the United States (US) and outside of the US (OUS) that participated in the pivotal study "A Prospective Multicenter Open-label Randomized Controlled Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee" (Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. Enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. As randomization was 2:1 in the pivotal study, the expected number of Marketed Product - MP01 and SSOC subjects enrolled into this study are approximately 114 and 56, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed Product - MP01 | – | Device: Marketed Product - MP01Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study. |
| Surgical Standard of Care - SSOC | – | Procedure: Surgical Standard of CareSubjects who had joint surface lesions of the knee randomized to be treated with Surgical Standard of Care (SSOC) - microfracture or debridement in the Pivotal study. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 170 subjects who had joint surface lesions of the knee, participated in the pivotal study and consent to continue follow-up will be enrolled.
Key inclusion criteria (3 listed)
- Participated in the pivotal study.
- Must be physically and mentally willing and able to comply with the follow-up schedule.
- Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
Key exclusion criteria (4 listed)
- Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
- Chemotherapy in the past 12 months.
- Participation in other clinical trials involving knee procedures.
- Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
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 |
|---|---|---|
| Marketed Product - MP01Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique. | Device | Marketed Product - MP01 |
| Surgical Standard of CareAs no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used. Deb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defects by creating small holes in the bone beneath the damaged cartilage. | Procedure or surgery | Surgical Standard of Care - SSOC |
Primary outcome
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
Time frame: Baseline and 7 years
Long-term effectiveness of Marketed Product - MP01 compared to SSOC measured by change in baseline to year 7 in overall KOOS (mean of Pain, Symptoms, Quality of Life (QOL), Function in Daily Living (ADL) and Sports subscales) in subjects treated with Marketed Product - MP01 vs SSOC. Baseline is defined as the pivotal study screening visit. Overall scores are converted to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).
11 secondary outcomes
Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)
Time frame: up to 10 years
Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections)
Time frame: up to 10 years
Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate
Time frame: up to 10 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
Time frame: Baseline and 7 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years
Time frame: Baseline and 10 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years
Time frame: Baseline and 7 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years
Time frame: Baseline and 10 years
Change from Baseline in Tegner Activity Scale Score at 7 Years
Time frame: Baseline and 7 years
Change from Baseline in Tegner Activity Scale Score at 10 Years
Time frame: Baseline and 10 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years
Time frame: Baseline and 7 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years
Time frame: Baseline and 10 years
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Samantha Andrews study chair
Smith & Nephew, Inc.
Galit Reske study chair
Smith & Nephew, Inc.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Joint Surface Knee Lesions, run by Smith & Nephew, Inc. at 8 sites in 6 countries.
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 4 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Serbia, United States, Belgium, Israel and 1 more country. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years (time frame: Baseline and 7 years). 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 16 Jul 2026.