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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AlSalam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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