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Outcomes of AllograftLongTermOCNCT02308358

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee

An observational study of Outcomes of Allograft, run by University of Missouri-Columbia at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Outcomes of Allograft
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2014to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients of orthopaedic surgeons in Columbia, Missouri at the University of Missouri-Columbia Hospital and Clinics.

Who may be able to join

  • Adults age ≥18 years
  • Femoral condyle osteochondral defect ≥10mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation, defect <10mm for microfracture treatment
  • Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
  • Must be able and willing to follow a standardized rehabilitation protocol.
  • Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
  • Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.

Who cannot join

  • 1. Presence of ipsilateral articular fractures, knee ligament injuries or extensor mechanism injuries
  • 2. Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage.
  • 3. Presence of a previous below knee amputation
  • 4. Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout)
  • 5. Is a prisoner
  • 6. Is receiving workman's compensation
  • 8. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements
  • 9. Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri-Hospital and Clinics

    Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee.

The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

Read the detailed description

Localized articular cartilage defects are a common and challenging problem, particularly in young patients. These defects cause significant disability and, as participation in sports activity grows, are increasing in overall number annually. A recent systematic review evaluating the overall full-thickness focal chondral defects in athletes revealed the prevalence to be 36%, with 22% of the athletes being symptomatic. As the prevalence of these injuries increases, they pose increasingly significant challenges to the clinicians who treat them.

Normal joint cartilage is a firm, elastic tissue that covers the ends of bones to protect them and allow smooth, pain-free movement over each other. Joint cartilage is described, macroscopically and microscopically, as articular or "hyaline" cartilage. Hyaline cartilage is often described as a "glass-like" structural tissue because of its shiny appearance and translucency. The tissue structure is a hydrated matrix consisting of proteoglycans and at least 90% (dry weight) Type II collagen fibers. The collagen fibers contribute to the overall tensile strength and the proteoglycans provide the stiffness and tissue resiliency. Cartilage cells, or chondrocytes, produce dense matrix, which effectively incarcerate the cells themselves. In the event of injury, the motility of these cells is restricted due to their inclusion deep inside the matrix, and the avascularity of the cartilage itself. This lack of a vascular network prevents the infiltration of inflammatory cells and bioactive molecules following damage. Thus, once damaged, adult articular cartilage will not effectively heal or regenerate.

Treatment techniques of osteochondral lesions are relatively new and frequently changing and evolving. The treatment algorithms for these injuries are complex and often involve multiple procedures, including non-surgical interventions with pharmacological agents such as oral non-steroidal anti-inflammatory drugs (NSAIDs), injectable corticosteroids, and activity modification including rehabilitation and support braces that may provide incomplete or temporary relief. Lesion characteristics such as grade and thickness may also impact treatment options and recovery. Arthroscopic debridement and lavage is effective as a first-line surgical approach for subjects with low physical demands. This procedure eliminates debris and decreases inflammation in the joints, but the symptomatic relief is usually transient and the lesion is not repaired. Treatments providing long-term results may be achieved through a variety of surgical options.

There are many surgical treatments options currently available and each have limitations. Marrow stimulation techniques include microfracture, drilling, and abrasion arthroplasty. The Microfracture technique has been described to address lesions up to 1 cm2 while other authors cite more specific applications depending on lesion size, patient age and physical demands. While microfracture is considered a reparative treatment, the procedure can produce less than optimal results because of the inferior nature of fibrocartilaginous tissue formed. Unlike the Type II collagen normally found in articular cartilage, fibrocartilage consists predominately of Type I collagen. Because it lacks the long-term wear characteristics of normal hyaline cartilage, fibrocartilage can degrade with time.

ACI is a two-staged procedure developed to treat cartilage defects in the knee. For ACI, a primary arthroscopic procedure is performed to assess the defect and a small amount (200mg to 400 mg) of healthy, autologous cartilage is harvested. The tissue is then expanded using a cell-culture process over a period of several weeks. The expanded cells are then implanted into the area of the defect during a second surgical procedure. Studies have demonstrated through histology and quantitative measurements that ACI produces a "hyaline-like cartilage" with a collagen type II content of between 35 percent and 55 percent. Literature indicates that hyaline cartilage may have greater biomechanical strength and integrity than the fibrocartilaginous tissue generated in lesions treated with microfracture. There are several disadvantages using ACI, however, such as the need for two surgeries. It has increased surgical time due to and it is associated with substantial cost to account for ex vivo cell expansion. Potential postoperative complications related to the periosteal patch include cell leakage, hypertrophy and/or delamination, and unequal chondrocyte distribution within the lesion.

Osteochondral grafting, the direct transplantation of an osteochondral autograft or allograft, is the only technique available on the market that transplants intact hyaline cartilage. Fresh osteochondral allografts use active chondrocytes while avoiding donor site morbidity. The grafts are avascular and aneural, meaning they are immunopriveleged and suitable for transplantation. Autograft plugs are typically used to treat small defects (up to 2.5 cm in diameter) due to donor site size limitation. Osteochondral allografts can be harvested up to 35 mm in diameter or an entire compartment can be resurfaced using a shell technique.Clinical outcome of osteochondral autografts has been documented in various studies as good to excellent, particularly in subjects with isolated femoral lesions. A major benefit of osteochondral allografts is their ability to provide the surgeon with the capability to treat much larger defects. A major drawback of many of the aforementioned treatment options (microfracture, ACI, osteochondral autograft) is their inability to treat such large lesions. Additionally, fresh OCA longevity after implantation has been documented to be as long as 25 years, indicating that this procedure can provide long term relief to patients.

The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

Keywords
Osteochondral Defect, Femoral condyle osteochondral defect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02308358
Study groupRoleWhat they receive
Allograft TransplantationSubjects with femoral condyle osteochondral defects ≥10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for allograft transplantation.
Microfracture TreatmentSubjects with femoral condyle osteochondral defects <10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for microfracture treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Level

    Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

    Measured: 1 Year

  2. Activity Level

    Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Why it stopped: New study initiated to replace this one

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308358
Sponsor's protocol ID
1210204
Acronym
LongTermOC
Status last verified
Aug 2023
First submitted
14 Nov 2014
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Outcomes of Allograft, run by University of Missouri-Columbia at 1 site 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pain Level (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 30 Aug 2023.

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