Patellofemoral OsteoarthritisPELICANNCT06423300
Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
A study testing LIFT Implant and Tibial Tubercle Osteotomy in people with Patellofemoral Osteoarthritis, run by ZKR Orthopedics Inc at 5 sites in United States.
Trial summary
The PELICAN study is a prospective, non randomized, dual arm, multi-center clinical study comparing clinical outcomes of subjects treated with the LIFT Implant System to subjects treated with Tibial Tubercle Osteotomy (TTO). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- LIFT Implant and Tibial Tubercle Osteotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Jun 2024to Sep 2031
- Phase
- Interventional
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 22 to 65 years at time of screening
- Anterior knee pain due to patellofemoral cartilage degeneration (PCD) with an Modified Outerbridge score of ≥3 as assessed by an MRI on the study knee
- Body Mass Index (BMI) of ≤ 35
- Weight < 300 lbs
- Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
- Visual Analog Score (VAS) of ≥ 40 (0-100 scale)
- Failure of at least 6 months of non-surgical treatment defined as at least one of the treatments (e.g. rest, bracing, physical therapy, targeted exercise, use of NSAIDs, activity level reduction or Confidential ZKR Orthopedics, CIP 0001 Page 11 of 55 Protocol Version: 1.0, 04JAN2024 modification, etc.) per AAOS Treatment of Osteoarthritis of the Knee; Evidence based guideline 3rd Edition 2021
Who cannot join
- PCD with an Modified Outerbridge Score of 2 or less at the study knee
- Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device
- History of patella dislocation or instability
- Patella alta or patella baja
- Known TT-TG distance >20mm
- Patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation
Show all 18Show fewer
- Previous repair of a torn patellar tendon
- Prior TTO procedure or knee joint replacement (total or partial) of the study knee
- Joint modifying surgery (e.g., ligament reconstruction, meniscus repair, cartilage transplantation, microfracture, etc.) in the study knee within 6 months prior to planned index procedure date
- Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure
- Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint
- Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
- History of avascular necrosis of any bone
- History of symptomatic patellar tendonitis of intrasubstance tear
- Insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the LIFT System
- Pathologic ligamentous injury (Lachman > 1) or meniscus tearing
- Clinical symptoms of the femoral-tibial joint of the study knee that preclude activities of daily living, stair climbing, stair descending, or requires the use of an assist device
- Evidence (MRI, arthroscopy, etc.) of Modified Outerbridge Grade 4 degenerative arthritis in the femoral-tibial joint of the study knee that potentially explains patient symptoms
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Ohio State University - Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
Jenna DeFranco, jenna.defranco@osumc.edu
David Flanigan, MD
- Recruiting
Horizon Clinical Research
La Mesa, California, 91942
Dino Subasic, dino@horizontrials.com
Scott Hacker, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Hannah Terry, terryh@hss.edu
Sabrina Strickland, MD
- Recruiting
NYU Langone Health
New York, New York, 11220
Ivanka Bhambhani, ivanka.bhambhani@nyulangone.org
Alexander Golant, MD
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Jessica Ballin, ballin@ohsu.edu
Dennis Crawford, MD
About this study
The PELICAN study is a prospective, non randomized, dual arm, multi-center clinical study comparing clinical outcomes of subjects treated with the LIFT Implant System to subjects treated with Tibial Tubercle Osteotomy (TTO).
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- LIFT Implant, Tibial Tubercle Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT ImplantDevice
The LIFT implant provides a less invasive option for treatment of patellofemoral cartilage degeneration in the knee. the LIFT implant unloads the patellofemoral joint by elevating the patellar tendon to unload the joint compartment and realign the kneecap toward healthier cartilage
Tibial Tubercle OsteotomyOther
Tibial Tubercle Osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group: LIFT | Experimental | Subjects receiving the LIFT implant system. Receives: Device: LIFT Implant |
| Control Group: TTO | Active comparator | Subjects receiving a Tibial Tubercle Osteotomy (TTO) Receives: Other: Tibial Tubercle Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
The Composite Endpoint is comprised of the following:
- an improvement of >10 points from baseline in the Anterior Knee Pain Scale (AKPS)
- Freedom from serious procedure-related adverse events leading to secondary surgical intervention (SSI).
- As determined by x-ray or MRI: Freedom from loosening of implant, loosening of bone screws, breakage of screw or implant, migration of implant; TTO osseous non-union, partial union, delayed union, malunion in any plane, TTO screw loosening, TTO screw breakage
The above 3 measures are COMBINED to produce the composite endpoint. If the subject meets all 3 outcome measures above at the 24 month mark - the outcome is listed as "non inferiority of the LIFT System as compared to TTO"
Measured: 24 months
Secondary outcomes (6)
Time to Partial Weight Bearing (Recovery)
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing.
Measured: 24 months
Time to Full Weight Bearing Without Assistive Devices (Recovery)
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to full weight bearing without the use of assistive devices.
Measured: 24 months
Function
Superiority of the LIFT system to TTO data for:
Functional Outcome: Early Functional Improvement as determined by the baseline change of the AKPS (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score.
Measured: 3 Months
Function
Superiority of the LIFT system to TTO data for:
Functional Outcome: Late Functional Improvement as determined by the baseline change of the AKPS Score (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score.
Measured: 24 Months
Patient's Reported Pain Level
Superiority of the LIFT system to TTO data for:
Early pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 3 months
Measured: 3 Months
Patient's Reported Pain Level
Superiority of the LIFT system to TTO data for:
Late pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 24 months
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start19 Jun 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZKR Orthopedics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423300
- Sponsor's protocol ID
- CIP0001
- Acronym
- PELICAN
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
- ClinicalTrials.gov ID
- NCT06423300
- Acronym / sponsor ID
- PELICAN / CIP0001
- Conditions
- Patellofemoral Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- ZKR Orthopedics IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 21 May 2024 (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 PELICAN study is a prospective, non randomized, dual arm, multi-center clinical study comparing clinical outcomes of subjects treated with the LIFT Implant System to subjects treated with Tibial Tubercle Osteotomy (TTO).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group: LIFT | Experimental | Device: LIFT ImplantSubjects receiving the LIFT implant system. |
| Control Group: TTO | Active comparator | Other: Tibial Tubercle OsteotomySubjects receiving a Tibial Tubercle Osteotomy (TTO) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients age 22 to 65 years at time of screening
- Anterior knee pain due to patellofemoral cartilage degeneration (PCD) with an Modified Outerbridge score of ≥3 as assessed by an MRI on the study knee
- Body Mass Index (BMI) of ≤ 35
- Weight < 300 lbs
- Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
Key exclusion criteria (18 listed)
- PCD with an Modified Outerbridge Score of 2 or less at the study knee
- Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device
- History of patella dislocation or instability
- Patella alta or patella baja
- Known TT-TG distance >20mm
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 |
|---|---|---|
| LIFT ImplantThe LIFT implant provides a less invasive option for treatment of patellofemoral cartilage degeneration in the knee. the LIFT implant unloads the patellofemoral joint by elevating the patellar tendon to unload the joint compartment and realign the kneecap toward healthier cartilage | Device | Treatment Group: LIFT |
| Tibial Tubercle OsteotomyTibial Tubercle Osteotomy | Other | Control Group: TTO |
Primary outcome
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
Time frame: 24 months
The Composite Endpoint is comprised of the following: 1. an improvement of >10 points from baseline in the Anterior Knee Pain Scale (AKPS) 2. Freedom from serious procedure-related adverse events leading to secondary surgical intervention (SSI). 3. As determined by x-ray or MRI: Freedom from loosening of implant, loosening of bone screws, breakage of screw or implant, migration of implant; TTO osseous non-union, partial union, delayed union, malunion in any plane, TTO screw loosening, TTO screw breakage The above 3 measures are COMBINED to produce the composite endpoint. If the subject meets all 3 outcome measures above at the 24 month mark - the outcome is listed as "non inferiority of the LIFT System as compared to TTO"
6 secondary outcomes
Time to Partial Weight Bearing (Recovery)
Time frame: 24 months
Time to Full Weight Bearing Without Assistive Devices (Recovery)
Time frame: 24 months
Function
Time frame: 3 Months
Function
Time frame: 24 Months
Patient's Reported Pain Level
Time frame: 3 Months
Patient's Reported Pain Level
Time frame: 24 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 11 Dec 2025.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT Implant and Tibial Tubercle Osteotomy in people with Patellofemoral Osteoarthritis, run by ZKR Orthopedics Inc at 5 sites in United States.
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 7 inclusion and 18 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Sharon Branch (9543033777, clinadmin@zkrorthopedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO. (time frame: 24 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 11 Dec 2025.