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

NCT07769632 | Not Yet Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: PH1-NHRA23-01Salmania Medical Complex
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

Osteoarthritis; Kellgran and Lawrence; Knee joint; Total knee Replacement; Allogenic graft

Outcome Measures

Primary Outcomes (2)

• Assessment of Allograft in osteoarthritis of knee

  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) .

  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.

Study Arms (1)

For osteoarthritis of knee grade II and III

EXPERIMENTAL

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.; Device: allogenic bone and cartilage graft

Interventions

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

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

Also known as: Allogenic, Femoral cartilage, Proximal Tibia

For osteoarthritis of knee grade II and III

allogenic bone and cartilage graft DEVICE

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

Also known as: allogenic, bone, cartilage, meniscus, bone and cartilage graft

For osteoarthritis of knee grade II and III

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AlSalam Hospital: lead

Study Sites (1)

AlSalam Specialist Hospital

Manama, 80278, Bahrain

Location

Related Publications (6)

• Gelber PE, Erquicia JI, Ramirez-Bermejo E, Farinas O, Monllau JC. Fresh Osteochondral and Meniscus Allografting for Post-traumatic Tibial Plateau Defects. Arthrosc Tech. 2018 May 28;7(6):e661-e667. doi: 10.1016/j.eats.2018.02.010. eCollection 2018 Jun.

  PMID: 30013907 RESULT

• Kaarre J, Herman ZJ, Zsidai B, Grassi A, Zaffagnini S, Samuelsson K, Musahl V. Meniscus allograft transplantation for biologic knee preservation: gold standard or dilemma? Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):3579-3581. doi: 10.1007/s00167-022-07187-w. Epub 2022 Oct 7. No abstract available.

  PMID: 36205759 RESULT

• Southworth TM, Naveen NB, Tauro TM, Chahla J, Cole BJ. Meniscal Allograft Transplants. Clin Sports Med. 2020 Jan;39(1):93-123. doi: 10.1016/j.csm.2019.08.013.

  PMID: 31767113 RESULT

• Gross AE, Shasha N, Aubin P. Long-term followup of the use of fresh osteochondral allografts for posttraumatic knee defects. Clin Orthop Relat Res. 2005 Jun;(435):79-87. doi: 10.1097/01.blo.0000165845.21735.05.

  PMID: 15930924 RESULT

• Volkov M. Allotransplantation of joints. J Bone Joint Surg Br. 1970 Feb;52(1):49-53. No abstract available.

  PMID: 4314242 RESULT

• Gross AE, Silverstein EA, Falk J, Falk R, Langer F. The allotransplantation of partial joints in the treatment of osteoarthritis of the knee. Clin Orthop Relat Res. 1975 May;(108):7-14. doi: 10.1097/00003086-197505000-00003.

  PMID: 1139838 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

allogenic effect factor

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mir Sadat-Ali, FRCS, PhD

  US Consultancy for Applied Research

  STUDY DIRECTOR

Central Study Contacts

Jamal Saleh, FRCS

CONTACT

+97336599999; drjslaeh@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic and Arthroplasty sugeon

Model Details: Using TOCR in the treatment of osteoarthritis of knee.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: November 2026 to October 2027
• Access Criteria: will share later

Locations

BA (1)