Efficacy of bone marrow concentrate injection in the treatment of knee osteoarthritis in the elderly
| ISRCTN | ISRCTN30143929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30143929 |
| Sponsors | Universidade Nova de Lisboa, Centro Hospitalar de Lisboa Ocidental |
| Funder | Centro Clínico Académico de Lisboa (CCAL), Lisbon Clinical Academic Centre, Portugal |
- Submission date
- 24/11/2025
- Registration date
- 25/11/2025
- Last edited
- 25/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jorge Barbosa
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
Unidade Local de Saúde de Lisboa Ocidental
Hospital de São Francisco Xavier
Serviço de Medicina Física e de Reabilitação
Estrada do Forte do Alto do Duque
Lisboa
1449-005
Portugal
 ORCID ID |
0000-0002-0856-9889 |
|---|---|
| Phone | +351 210431740 |
| jbarbosa@ulslo.min-saude.pt |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Efficacy of intra-articular injection of bone marrow concentrate in the treatment of knee osteoarthritis in elderly patients | |
| Study objectives | Main objective: To assess the efficacy of intra-articular injection of bone marrow concentrate in the treatment of symptomatic knee osteoarthritis in elderly patients, compared with a control group treated with hyaluronic acid injection (viscosupplementation). Secondary objective: To assess whether there is a relationship between dose and efficacy. | |
| Ethics approval(s) |
Approved 02/06/2025, Comissão de Ética para a Saúde da Unidade Local de Saúde de Lisboa Ocidental - Health Ethics Committee of the Western Lisbon Local Health Unit (Unidade Local de Saúde de Lisboa Ocidental, Hospital de Egas Moniz, Rua da Junqueira, 126, Lisboa, 1349-019, Portugal; +351 210432665; anavalho@ulslo.min-saude.pt), ref: Approval code: 2025-76; RNEC registry number: 20170700050 | |
| Health condition(s) or problem(s) studied | Knee osteoarthritis | |
| Intervention | After meeting elegibility criteria and signing informed consent, the participants will be assigned in 1 of 2 possible groups. Intervention group (n = 45) - ultrasound guided iliac crest bone marrow aspiration and subsequent centrifugation, obtaining a concentrate (from which a sample is sent for analysis), followed by an ultrasound-guided injection into the knee joint Control group (n = 45) - ultrasound-guided viscosupplementation (knee intra-articular injection of hyaluronic acid) Participants will be randomly assigned in a 1:1 ratio to the intervention or control group using a computer-generated randomization, with different block sizes. Different investigators will be responsible for the randomization, the allocation process (with opaque sealed envelopes) and the treatment. There will be blinding of the investigators performing the assessments regarding the treatment that was administered Besides demographic and medical background data, there will be clinical, functional and generic health status assessments, before the treatment and at 1, 3, 6, and 12 months afterwards. There will be imaging assessments before the treatment and at 6 and 12 months afterwards Clinical assessments - knee pain Visual Analogue Scale (VAS), 10 meter walk test, Timed Up and Go Test, several knee physical exam parameters Functional and generic health status assessment - WOMAC and EQ-5D-5L scales Imaging assessment - X-ray (Kellgren-Lawrence scale and measurements) and MRI (WORMS score and measurements) | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | BioCUE®, Monovisc® | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 10/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Primary (idiopathic) femorotibial knee osteoarthritis (medial, lateral, or medial + lateral) 2. Diagnosis based on the clinical + radiographic criteria of the American College of Rheumatology for idiopathic knee osteoarthritis (knee pain + osteophytes + at least 1 of the following 3 criteria: age > 50 years, stiffness < 30 minutes, crepitus) 3. Knee symptoms mainly attributable to femorotibial osteoarthritis (medial, lateral, or medial + lateral), confirmed on physical examination 4. Pain and reduced lower limb mobility mainly attributable to the knee under study 5. Clinical presentation with average pain ≥ 5 (moderately severe) on the Visual Analogue Scale (VAS) for pain, on most days in the past month 6. Radiographic evidence of femorotibial osteoarthritis (medial, lateral, or medial + lateral) of Kellgren–Lawrence grade II or III, on a weight-bearing AP knee radiograph of the knee under study performed within the past year 7. Age ≥ 65 years 8. Willingness to participate in the study and sign the informed consent 9. If both knees meet the inclusion criteria, the knee selected for the study will be the one with the higher average pain on most days in the past month on the Visual Analogue Scale (VAS) for pain; if pain intensity is equal in both knees, the selected knee will be the one with more frequent pain (greater number of painful days in the past month) |
| Key exclusion criteria | 1. History of knee surgery and of injection with platelet-rich plasma, or with bone marrow, adipose tissue, or umbilical cord concentrate 2. History of knee injection with hyaluronic acid or hylan within the past year 3. History of percutaneous invasive knee procedure in the past 3 months 4. Sepsis 5. Skin integrity alterations or infection of the knee or iliac crest 6. Inability to walk and perform transfers independently 7. Known immunosuppression, due to disease or therapy 8. Active oncological disease in the affected knee or in the iliac bone 9. Active infectious disease or fever 10. Depression 11. Fibromyalgia 12. Severe mental illness 13. Severe cognitive impairment |
| Date of first enrolment | 10/12/2025 |
| Date of final enrolment | 10/12/2026 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Unidade Local de Saúde de Lisboa Ocidental
Estrada do Forte do Alto do Duque
Lisboa
1449-005
Portugal
Lisboa
1449-005
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
25/11/2025: Trial's existence confirmed by Comissão de Ética para a Saúde da Unidade Local de Saúde de Lisboa Ocidental - Health Ethics Committee of the Western Lisbon Local Health Unit.
