CompassionevsNCT06251869
Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)
An observational study of Compassion, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Compassion
- What is being tested?
- total hip arthroplasty with electrocoagulation, total hip arthroplasty without electrocoagulation and total knee arthroplasty with electrocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteRomania
- Study dates
- 15 Mar 2024to 15 Feb 2027
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: anyone who needs a hip/knee replacemnt
Who may be able to join
- Patients who have given informed consent to the procedure
- Patients admitted over 18 years of age
- Patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, Avascular necrosis (AVN) of the femoral head , femoral neck fractures, etc)
Who cannot join
- Contraindications for major surgery or anaesthesia
- Patients with active infections that could interfere with outcome assessment
- Patients unable to give informed consent for psychological or cognitive reasons
- Severe medical conditions such as coagulopathies that may significantly influence outcomes
- Patients unable or unwilling to adhere to the required follow-up period
- Patients who died during the study period
- Patients with revision prosthesis operations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ciornei Vladimir, MD contact
Romania1 site, 1 recruiting
- Recruiting
Clinica Ortopedie-Traumatologie, Secția 2
Cluj-Napoca, Cluj, 400347
BENEA R HOREA, MD, 0724528188 ext. +40, beneahorea@yahoo.com
BENEA R HOREA, MD
About this study
Official title: Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement
Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery
Read the detailed description
Objectives:
- To evaluate the effectiveness of electrocoagulation:
- To measure the reduction in intraoperative bleeding volume when using electrocoagulation.
- Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement.
- Comparison of surgical outcomes:
- Investigate the incidence of intra- and postoperative complications, such as incidental vascular-nerve injury, wound infections, deep vein thrombosis, and implant-related problems, in patients operated on with electrocoagulation versus techniques without electrocoagulation.
- Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery.
- Evaluation of long-term functional outcomes and patient satisfaction, including joint stability and range of motion, in both groups.
- Review of patient recovery and period of hospitalization:
- Analysis of the impact of electrocoagulation on length of hospitalisation, and time to ambulation.
- Assessment of postoperative pain levels and analgesic medication use between the two groups.
- Patients' return to daily activities and overall quality of life after surgery.
- Comparison of data obtained with other studies conducted internationally.
- Conditions
- Compassion
- Being tested
- total hip arthroplasty with electrocoagulation, total hip arthroplasty without electrocoagulation, total knee arthroplasty with electrocoagulation, total knee arthroplasty without electrocoagulation
- Keywords
- electrocoagulation, cold knife, scalpel, joint arthroplasty, knee replacement, hip replacement, comparative analysis, surgical techniques, orthopedics, outcome assessment
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplasty with electrocoagulationProcedure or surgery
using normal technique
total hip arthroplasty without electrocoagulationProcedure or surgery
using only scalpel and pean as hemostasis and incision
total knee arthroplasty with electrocoagulationProcedure or surgery
using normal technique
total knee arthroplasty without electrocoagulationProcedure or surgery
using only scalpel and pean as hemostasis and incision
| Study group | Role | What they receive |
|---|---|---|
| hip electrocoagulation | group subjected to the use of electrocoagulation Receives: Procedure: total hip arthroplasty with electrocoagulation | |
| hip scalpel | group subjected to the use of traditional hemostatic technique Receives: Procedure: total hip arthroplasty without electrocoagulation | |
| knee electrocoagulation | group subjected to the use of electrocoagulation Receives: Procedure: total knee arthroplasty with electrocoagulation | |
| knee scalpel | group subjected to the use of traditional hemostatic technique Receives: Procedure: total knee arthroplasty without electrocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168
Measured: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 .
Measured: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
International Knee Documentation Committee (IKDC) objective form
to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome .
Measured: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Harris Hip Score
to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 .
Measured: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-24 .
Measured: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Forgotten Joint Score
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-48 .
Measured: the test will be administered 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Secondary outcomes (12)
hemaglobin levels
for blood loss objectification .
Measured: the hemaglobin levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
leucocyte levels
for infection objectification .
Measured: the leucocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
thrombocyte levels
for blood loss objectification .
Measured: the thrombocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
mobilisation intervals of the patient
the investigators will asses the time for the self-mobilisation of the patient to sit at the bed's edge, and then mobilisation with a walking aid like a walking frame. .
Measured: through hospital stay of patient approximatively 4-7 days
joint hyperextension angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint flexion angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
genu flexum angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint external rotation angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint internal rotation angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint abduction angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint adduction angle
to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Measured: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Number of participants with complications
to objectify the superiority of one technique over the other, higher number signifies a worse outcome .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Mar 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CompassionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benea Horea, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Benea R Horea, MD, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251869
- Sponsor's protocol ID
- umfcj002
- Acronym
- evs
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sonntag R, Gibmeier J, Pulvermacher S, Mueller U, Eckert J, Braun S, Reichkendler M, Kretzer JP. Electrocautery Damage Can Reduce Implant Fatigue Strength: Cases and in Vitro Investigation. J Bone Joint Surg Am. 2019 May 15;101(10):868-878. doi: 10.2106/JBJS.18.00259.
PubMed 31094978Lacitignola L, Desantis S, Izzo G, Staffieri F, Rossi R, Resta L, Crovace A. Comparative Morphological Effects of Cold-Blade, Electrosurgical, and Plasma Scalpels on Dog Skin. Vet Sci. 2020 Jan 12;7(1):8. doi: 10.3390/vetsci7010008.
PubMed 31940962Lin W, Dai Y, Niu J, Yang G, Li M, Wang F. Scalpel can achieve better clinical outcomes compared with electric cautery in primary total knee arthroplasty: a comparison study. BMC Musculoskelet Disord. 2020 Jun 29;21(1):409. doi: 10.1186/s12891-020-03457-1.
PubMed 32600294Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
PubMed 22000572Cadeddu JA. Re: Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery. J Urol. 2015 Jan;193(1):129. doi: 10.1016/j.juro.2014.10.014. Epub 2014 Oct 12. No abstract available.
PubMed 25523661Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
PubMed 29968137Ozturk K, Kaya I, Turhal G, Ozturk A, Gursan G, Akyildiz S. A comparison of electrothermal bipolar vessel sealing system and electrocautery in selective neck dissection. Eur Arch Otorhinolaryngol. 2016 Nov;273(11):3835-3838. doi: 10.1007/s00405-016-3999-0. Epub 2016 Mar 23.
PubMed 27007131Groot G, Chappell EW. Electrocautery used to create incisions does not increase wound infection rates. Am J Surg. 1994 Jun;167(6):601-3. doi: 10.1016/0002-9610(94)90106-6.
PubMed 8209936
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement
- ClinicalTrials.gov ID
- NCT06251869
- Acronym / sponsor ID
- evs / umfcj002
- Conditions
- Compassion
- Keywords
- electrocoagulation, cold knife, scalpel, joint arthroplasty, knee replacement, hip replacement, comparative analysis, surgical techniques
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 9 Feb 2024 (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.
Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery
Detailed description
Objectives:
- To evaluate the effectiveness of electrocoagulation:
- To measure the reduction in intraoperative bleeding volume when using electrocoagulation.
- Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement.
- Comparison of surgical outcomes:
- Investigate the incidence of intra- and postoperative complications, such as incidental vascular-nerve injury, wound infections, deep vein thrombosis, and implant-related problems, in patients operated on with electrocoagulation versus techniques without electrocoagulation.
- Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery.
- Evaluation of long-term functional outcomes and patient satisfaction, including joint stability and range of motion, in both groups.
- Review of patient recovery and period of hospitalization:
- Analysis of the impact of electrocoagulation on length of hospitalisation, and time to ambulation.
- Assessment of postoperative pain levels and analgesic medication use between the two groups.
- Patients' return to daily activities and overall quality of life after surgery.
- Comparison of data obtained with other studies conducted internationally.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| hip electrocoagulation | – | Procedure: total hip arthroplasty with electrocoagulationgroup subjected to the use of electrocoagulation |
| hip scalpel | – | Procedure: total hip arthroplasty without electrocoagulationgroup subjected to the use of traditional hemostatic technique |
| knee electrocoagulation | – | Procedure: total knee arthroplasty with electrocoagulationgroup subjected to the use of electrocoagulation |
| knee scalpel | – | Procedure: total knee arthroplasty without electrocoagulationgroup subjected to the use of traditional hemostatic technique |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- anyone who needs a hip/knee replacemnt
Key inclusion criteria (3 listed)
- Patients who have given informed consent to the procedure
- Patients admitted over 18 years of age
- Patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, Avascular necrosis (AVN) of the femoral head , femoral neck fractures, etc)
Key exclusion criteria (7 listed)
- Contraindications for major surgery or anaesthesia
- Patients with active infections that could interfere with outcome assessment
- Patients unable to give informed consent for psychological or cognitive reasons
- Severe medical conditions such as coagulopathies that may significantly influence outcomes
- Patients unable or unwilling to adhere to the required follow-up period
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 hip arthroplasty with electrocoagulationusing normal technique | Procedure or surgery | hip electrocoagulation |
| total hip arthroplasty without electrocoagulationusing only scalpel and pean as hemostasis and incision | Procedure or surgery | hip scalpel |
| total knee arthroplasty with electrocoagulationusing normal technique | Procedure or surgery | knee electrocoagulation |
| total knee arthroplasty without electrocoagulationusing only scalpel and pean as hemostasis and incision | Procedure or surgery | knee scalpel |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score
Time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score
Time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 .
International Knee Documentation Committee (IKDC) objective form
Time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome .
Harris Hip Score
Time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 .
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score
Time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-24 .
Forgotten Joint Score
Time frame: the test will be administered 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-48 .
12 secondary outcomes
hemaglobin levels
Time frame: the hemaglobin levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
leucocyte levels
Time frame: the leucocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
thrombocyte levels
Time frame: the thrombocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months
mobilisation intervals of the patient
Time frame: through hospital stay of patient approximatively 4-7 days
joint hyperextension angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint flexion angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
genu flexum angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint external rotation angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint internal rotation angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint abduction angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
joint adduction angle
Time frame: the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op
Number of participants with complications
Time frame: through study completion, an average of 1 year
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 1 May 2025.
- Background: PubMed 31094978Sonntag R, Gibmeier J, Pulvermacher S, Mueller U, Eckert J, Braun S, Reichkendler M, Kretzer JP. Electrocautery Damage Can Reduce Implant Fatigue Strength: Cases and in Vitro Investigation. J Bone Joint Surg Am. 2019 May 15;101(10):868-878. doi: 10.2106/JBJS.18.00259.
- Background: PubMed 31940962Lacitignola L, Desantis S, Izzo G, Staffieri F, Rossi R, Resta L, Crovace A. Comparative Morphological Effects of Cold-Blade, Electrosurgical, and Plasma Scalpels on Dog Skin. Vet Sci. 2020 Jan 12;7(1):8. doi: 10.3390/vetsci7010008.
- Background: PubMed 32600294Lin W, Dai Y, Niu J, Yang G, Li M, Wang F. Scalpel can achieve better clinical outcomes compared with electric cautery in primary total knee arthroplasty: a comparison study. BMC Musculoskelet Disord. 2020 Jun 29;21(1):409. doi: 10.1186/s12891-020-03457-1.
- Background: PubMed 22000572Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
- Background: PubMed 25523661Cadeddu JA. Re: Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery. J Urol. 2015 Jan;193(1):129. doi: 10.1016/j.juro.2014.10.014. Epub 2014 Oct 12. No abstract available.
- Background: PubMed 29968137Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
- Background: PubMed 27007131Ozturk K, Kaya I, Turhal G, Ozturk A, Gursan G, Akyildiz S. A comparison of electrothermal bipolar vessel sealing system and electrocautery in selective neck dissection. Eur Arch Otorhinolaryngol. 2016 Nov;273(11):3835-3838. doi: 10.1007/s00405-016-3999-0. Epub 2016 Mar 23.
- Background: PubMed 8209936Groot G, Chappell EW. Electrocautery used to create incisions does not increase wound infection rates. Am J Surg. 1994 Jun;167(6):601-3. doi: 10.1016/0002-9610(94)90106-6.
- Individual participant dataSharing planned: Undecided
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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.
Ciornei Vladimir, MD contact
Benea R Horea, MD principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compassion, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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 Romania. 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.
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 Cicio Dennis (0752457783 ext. +4, ciciodennis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score (time frame: the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op). The study lists 6 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 NCT06251869, which also lists 8 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 1 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.