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

August 18, 2026 updated by: Sadat A Ali, AlSalam Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description Procedure for the TOCR: A cruciate knee replacement requires less bone and soft tissue resection. A more normal transmission of the weight-bearing stresses is possible compared to other knee Measures of Treatment Compliance: None. Study Procedures and Guidelines: replacements. Preserving both cruciate ligaments mandates the correct tension on all ligaments. Bi-cruciate retaining (BCR) TKA is considered to show improved clinical function and kinematics.The standard technique of the Bi-cruciate retaining (BCR) TKA is described. The importance of retaining both the cruciate ligaments cannot be over emphasized. In TOCR both the cruciate ligaments retained are native. The Cruciate ligaments, particularly the Anterior Cruciate Ligament (ACL), are vital for knee proprioception, acting as specialized sensors that inform the brain about knee position, movement, and load. They contain mechanoreceptors that initiate reflex muscle contractions to stabilize the joint. In standard TKR both the cruciate are removed making the stability on the implants. Figure I gives the standard cuts of the Femur and Tibia using the routine instrumentation of the Bi-cruciate retaining (BCR) TKA. During regular TKR, the bone segments removed are discarded, and this will follow the same procedure as TOCR. TOCR uses standard instrumentation of the bi-cruciate retaining TKR. All the cuts and procedures are similar to the TKR. Instead of metallic and polyethylene implants, a custom-matched Allograft of the femoral cartilage and Tibial plateau will be performed. The Allograft will be fixed with 2 Acutrak 2, 7.5mm X 120mm long, in the femur and tibia. The menisci will be sutured to the capsule of the native joint. The custom-matched allografts will be obtained by MTF Biologics, New Jersey, USA.The surgeons will carry out the initial 10 cases, and the cost will be borne by the Patent. Will take liability medical insurance for the patients to be treated if there are any complications. If the TOCR fails patients will undergo standard TKR and will be covered by the Insurance and Sponsors. The failure of the procedure could be infection which will be treated by antibiotics on out patient basis. As postoperatively patients will have routine physical therapy to strengthen the muscles and proper gait training for one month. The there is a failure of union then a bone graft can be further augmented and worse is to take out the allografts and perform the standard Total knee replacement. All patients will be instructed to report immediately to the hospital if any side effects are noted. Depending on the adverse effects, patients will continue or stop further treatment. All patients without or with adverse events will be followed for 36 months from the time they were operated on. All Adverse Events (AEs) were noted at every visit and were graded based on the intensity (mild, moderate, or severe) and relevance (serious, non-serious). Standard cuts of the Femur or Tibia in TKR. Schematic image of the post fixation in TOCR. Cadaveric Allografts of the Femur and Tibial Plateau. FIGURE I: Standard cuts of the Femur or Tibia in TKR.FIGURE II: Schematic image of the post fixation in TOCR Cadaveric TOCR. Figure IV: Cadaveric Allografts of the Femur and Tibial Plateau after fixation. Post-surgery patients will have the routine mobilization protocol by physical therapy as for standard TKR.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bahrain
      • Manama, Bahrain, 80278
        • AlSalam Specialist Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Jamal Saleh, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Agreeing to participate and signing informed consent voluntarily.

Exclusion Criteria:

  • 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)
  • Patients who will not consent to follow-up.
  • Mental disorders and drug dependency (Patients who cannot understand the consent or the procedure of the TOCR).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: For osteoarthritis of knee grade II and III
Total Osteo Cartilage replacement will be replaced using allogenic bone and cartilage graft with meniscus
Biological: Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.
IN total knee replacement metallic and plastic implant is used but in this procedure allograft with bone, cartilage and meniscus will be used.
Other Names:
  • Allogenic
  • Femoral cartilage
  • Proximal Tibia
Device: allogenic bone and cartilage graft
In this study allograft will be used instead of metallic and plastic implants.
Other Names:
  • allogenic
  • bone
  • cartilage
  • meniscus
  • bone and cartilage graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Allograft in osteoarthritis of knee
Time Frame: 36 months
The outcome of the allograft will be assessed by union of the allograft with the native bone.
36 months
assessment range of movements using WOMAC (Western Ontario University McMaster Osteoarthritis Index) .
Time Frame: 3,6,9,12, 18, 24 and 36 months.
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).
3,6,9,12, 18, 24 and 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlSalam Hospital

Investigators

  • Study Director: Mir Sadat-Ali, FRCS, PhD, US Consultancy for Applied Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

August 12, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH1-NHRA23-01
  • Salmania Medical Complex (Other Identifier: AlSalam Specialist Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

not decided yet

IPD Sharing Time Frame

November 2026 to October 2027

IPD Sharing Access Criteria

will share later

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Study Protocol
    Information identifier: dr jamal Saleh
    Information comments: www.nhra.bh, TOCR STUDY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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