Total Osteo-Cartilage Replacement for the Treatment of Osteoarthritis of Knee

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age45-70
SponsorAlSalam Hospital

About this trial

Young patients who require total knee arthroplasty with metallic and plastic implants will undergo femoral condyle cartilage and top of the tibia with meniscus replacement. With the proposed surgery patients will have increased range of movements so that they can sit on the ground to fulfill their social was of life, which is not possible with the standard of care total knee replacement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being between 45 and 70 years of age of either gender. (OAK is common in this Age group)

Diagnosed with OAK with Kellgren and Lawrence Grading III and IV.

No ligamentous laxity and varus or valgus deformity. (In standard TKR patients with ligamentous laxity Constrained Condylar Knee (CCK) with intramedullary stem is used).

Patients who wish to have an active lifestyle.

Disqualifiers

Previous knee surgery within six months.

Uncontrolled Diabetes Mellitus

Chronic Kidney Disease. (Patients on hemodialysis)

Metabolic bone disease. (Severe osteoporosis with T Score of -<3.5)

Trial design

Design model

Single group

Treatments tested in this trial

  • Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.

    Biological/Vaccine

    IN total knee replacement metallic and plastic implant is used but in this procedure allograft with bone, cartilage and meniscus will be used.

  • allogenic bone and cartilage graft

    Device

    In this study allograft will be used instead of metallic and plastic implants.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: For osteoarthritis of knee grade II and IIIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assessment of Allograft in osteoarthritis of knee

The outcome of the allograft will be assessed by union of the allograft with the native bone.

Time frame
36 months
2

assessment range of movements using WOMAC (Western Ontario University McMaster Osteoarthritis Index) .

pain=0-20, stiffness=0-8, physical function=0-68. a total WOMAC score is created by summing the items for all three subscales (max score 96).

Time frame
3,6,9,12, 18, 24 and 36 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: