Osteoarthritis (OA) of the KneeEarly Phase 1NCT07769632
Total Osteo-Cartilage Replacement for the Treatment of Osteoarthritis of Knee
A Early Phase 1 study testing Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus. and allogenic bone and cartilage graft in people with Osteoarthritis (OA) of the Knee, run by AlSalam Hospital at 1 site in Bahrain.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus. and allogenic bone and cartilage graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBahrain
- Study dates
- 1 Nov 2026to 31 Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bahrain1 site
AlSalam Specialist Hospital
Manama, 80278
Jamal Saleh, FRCS,, +97336599999, drjsaleh@gmail.com
Mir Sadat-Ali, FRCS, PhD, +97339309939, drsadat@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus., allogenic bone and cartilage graft
- Keywords
- Osteoarthritis, Kellgran and Lawrence, Knee joint, Total knee Replacement, Allogenic graft
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.Biological
Also called Allogenic, Femoral cartilage, Proximal Tibia
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 graftDevice
Also called allogenic, bone, cartilage, meniscus
In this study allograft will be used instead of metallic and plastic implants.
| Study group | Role | What they receive |
|---|---|---|
| For osteoarthritis of knee grade II and III | Experimental | Total Osteo Cartilage replacement will be replaced using allogenic bone and cartilage graft with meniscus Receives: Biological: Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.; Device: allogenic bone and cartilage graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Allograft in osteoarthritis of knee
The outcome of the allograft will be assessed by union of the allograft with the native bone.
Measured: 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).
Measured: 3,6,9,12, 18, 24 and 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using TOCR in the treatment of osteoarthritis of knee.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlSalam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadat A Ali, AlSalam Hospital
- Investigators
- Mir Sadat-Ali, FRCS, PhD, Study director, US Consultancy for Applied Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769632
- Sponsor's protocol ID
- PH1-NHRA23-01
- Other IDs
- Salmania Medical Complex
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: not decided yet
Publications
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.
PubMed 30013907Kaarre 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.
PubMed 36205759Southworth 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.
PubMed 31767113Gross 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.
PubMed 15930924Volkov M. Allotransplantation of joints. J Bone Joint Surg Br. 1970 Feb;52(1):49-53. No abstract available.
PubMed 4314242Gross 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.
PubMed 1139838
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Osteo-Cartilage Replacement for the Treatment of Osteoarthritis of Knee
- ClinicalTrials.gov ID
- NCT07769632
- Acronym / sponsor ID
- PH1-NHRA23-01
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- Osteoarthritis, Kellgran and Lawrence, Knee joint, Total knee Replacement, Allogenic graft
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AlSalam HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using TOCR in the treatment of osteoarthritis of knee.
| Arm | Type | Receives |
|---|---|---|
| For osteoarthritis of knee grade II and III | Experimental | Biological: Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus., Device: allogenic bone and cartilage graftTotal Osteo Cartilage replacement will be replaced using allogenic bone and cartilage graft with meniscus |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus.Also: Allogenic, Femoral cartilage, Proximal TibiaIN total knee replacement metallic and plastic implant is used but in this procedure allograft with bone, cartilage and meniscus will be used. | Biological | For osteoarthritis of knee grade II and III |
| allogenic bone and cartilage graftAlso: allogenic, bone, cartilage, meniscusIn this study allograft will be used instead of metallic and plastic implants. | Device | For osteoarthritis of knee grade II and III |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 30013907Gelber 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.
- Results publication: PubMed 36205759Kaarre 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.
- Results publication: PubMed 31767113Southworth 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.
- Results publication: PubMed 15930924Gross 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.
- Results publication: PubMed 4314242Volkov M. Allotransplantation of joints. J Bone Joint Surg Br. 1970 Feb;52(1):49-53. No abstract available.
- Results publication: PubMed 1139838Gross 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.
- Individual participant dataSharing planned: Yes. not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mir Sadat-Ali, FRCS, PhD study director
US Consultancy for Applied Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Total osteo-cartilage replacement of the distal femur and proximal tibia, including medial and lateral meniscus. and allogenic bone and cartilage graft in people with Osteoarthritis (OA) of the Knee, run by AlSalam Hospital at 1 site in Bahrain.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Aug 2026. 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 Bahrain. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamal Saleh, FRCS (+97336599999, drjslaeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Allograft in osteoarthritis of knee (time frame: 36 months). 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?
On the ClinicalTrials.gov record for NCT07769632, which also lists 6 linked publications.
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 19 Aug 2026.