Joint DiseasesNCT06074744
Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty
A study testing SSNB + IPACK and FNB + IPACK in people with Joint Diseases and Joint Pain, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is: is there a benefit in functional muscle power output of the leg? Participants will be randomized into either the intervention group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Diseases, Joint Pain
- What is being tested?
- SSNB + IPACK and FNB + IPACK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Nov 2023to Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18yrs
- primary TKA
- BMI 35kg/m2 or less
- able to give informed consent as documented by signature
- clinical history without any contraindications for the planned intervention
Who cannot join
- age < 18 years
- revision-TKA
- BMI >35kg/m2
- absent contact information
- inability or contraindications to undergo the investigated intervention (TKA, FNB, SSNB), - clinically significant concomitant diseases
- pregnancy
- inability to follow the procedures and follow-up procedures of the study (e.g. due to language problems, psychological disorders, dementia, living abroad, etc.
- withdrawal from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Judith Bering, Dr. med., +41-41-2051891, judith.bering@luks.ch
Laura V Buchmann, Dr. med., +41-41-2057855, laura.buchmann@luks.ch
About this study
Official title: Subsartorial Saphenous Nerve Block (SSNB) Versus Femoral Nerve Block (FNB) in Primary Total Knee Arthroplasty (TKA) Combined With Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK) - Where Are the Benefits?
The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is:
- is there a benefit in functional muscle power output of the leg?
Read more
Participants will be randomized into either the intervention group or the control group and:
- receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1)
- receive Femoral Nerve Block (FNB) + IPACK in control group (group 2)
Researchers will compare the 2 groups to see if there are differences in :
- functional muscle power output of the leg?
- muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?
Read the detailed description
Prospective, randomized, double-blinded, single-center, controlled clinical trial with intervention group (SSNB + IPACK, group 1) and control group (FNB + IPACK, group 2), randomization by sealed envelopes.
The number of participants will be 72 per group, calculated based on a sample size calculator program.
The 3 surgeons will be blinded as well as the patients regarding the nerve block they will receive.
We will explain to the patients how both the blocks will be carried out, that 1 block will be located "higher on the leg" and 1 "lower on the leg". The nerve blocks will be carried out by a well-trained anaesthesiologist following standard procedures preoperative.
The IPACK will be applied by the surgeons intraoperative, following a standard protocol. The used implant for all patients will be the cemented ATTUNE™ Primary Knee System® (DePuySynthes Johnson\&Johnson).
Every patient will wear a brace fixed in full extension after surgery for the first 24 hours. Postoperative all patients will receive a standard set of adequate analgesics.
The postoperative rehabilitation program will follow our well-established physiotherapy scheme.
Performed assessments:
- Range of motion (ROM)
- medical history
- physical examinations
- radiologic controls
- adverse events
- falls during hospital stay (standard protocol)
- pain assessment (numeric rating scale)
- Questionnaires (EQ-5D-5L und Oxford Knee Score) will be filled in by the patients
- Functional assessment: Cycle sprint test one a specially instrumented indoor bike (Verve Info Tec PTY LTD) fit with an instrumented crank (InfoCrank Power Meter, Verve Cycling, West Perth, Australia)
- Functional assessment: Manual muscle testing (MMT)
- Functional assessment: Timed up and go test (TUG)
Superiority analysis using a two sample t-test, significance level 0.05, power 80%.
Data will be stored electronically in the data base (RedCap). In case of missing data there will always be attempts to obtain these data afterwards (contacting the patients by phone). Further on statistical analysis is performed.
Dropouts, before the 6 weeks follow-up, will be replaced by recruitment of new subjects.
For quality assurance the sponsor, the Ethics Committee or an independent trial monitor may visit the research sites.
- Conditions
- Joint Diseases, Joint Pain
- Being tested
- SSNB + IPACK, FNB + IPACK
- Keywords
- Subsartorial Saphenous Nerve Block (SSNB), Femoral Nerve Block (FNB), Total Knee Arthroplasty (TKA)
- Medical subject headings
- Joint Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSNB + IPACKOther
Also called Subsartorial Nerve Block
already included in arm/group description
FNB + IPACKOther
Also called Femoral Nerve Block
already included in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: SSNB + IPACK (group 1) | Active comparator | Subsartorial Nerve Block:
* 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
* anatomic landmarks: proximal adductor channel, intersection of the medial borders of the sartorius muscle and the adductor longus, guided by ultrasound control
* no patch to puncture site to not jeopardise the surgeon's blinding
* IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation Receives: Other: SSNB + IPACK |
| Control group: FNB + IPACK (group 2) | Active comparator | Femoral Nerve Block:
* 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
* anatomic landmarks: lateral to the femoral artery,level of the femoral crease (proximal to the vascular outlet of the deep artery of the thigh), femoral nerve lies on the surface of the iliopsoas muscle and is covered by the fascia iliaca, guided by ultrasound control
* no patch to puncture site to not jeopardise the surgeon's blinding
* IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation Receives: Other: FNB + IPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional muscle power output of the leg
Cycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better)
Measured: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Secondary outcomes (9)
Muscle strength
Manual muscle testing (MMT) as a standardized measuring tool to assess quadriceps muscle strength using a numeric score 0-5 (Daniels and Worthingham Scale): patient in sitting position in 20 degree knee flexion is asked to extend the knee actively against resistance proximal to the ankle (higher values better)
Measured: preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Mobility
Timed up and go test (TUG): standardized measuring tool, the patient is timed while they rise from an arm chair (approximate seat height 46 cm), walk at a comfortable and safe pace to a line on the floor 3 metres away, turn and walk back to the chair and sit down again (in seconds) (lower values better)
Measured: preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery
Clinical results
redness, swelling, hyperthermia, wound/scar, range of motion, stability, adverse events
Measured: preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery
Radiological results
x-rays ap and lateral view(1), patella(2), whole leg axis(3)
Measured: preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3)
Pain control
numeric rating scale 0-10 (lower values better)
Measured: before surgery, twice daily on the ward (except first 6 hours: hourly), day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Opioid consumption
documentation of administered drugs including name of drug, dosage, frequency of use
Measured: before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Length of hospital stay
documentation of days in hospital
Measured: before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 1
Questionnaire (Oxford Knee Score) 12-60 points (lower values better)
Measured: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 2
Questionnaire (EQ-5D-5L) 5 questions with 5 answers each (lower values better) including EQ-VAS 0-100 (higher values better)
Measured: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Joint DiseasesStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Bering, Luzerner Kantonsspital
- Investigators
- Judith Bering, Dr. med., Principal investigator, Luzerner Kantonsspital Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074744
- Sponsor's protocol ID
- SSNB2023
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Declaration of Helsinki, Version October 2013
International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical Practice
International Conference on Harmonization (ICH, 1997) E8 Guideline: General Considerations for Clinical Trials
Implantatregister SIRIS Hüfte und Knie: Kurzfassung - SIRIS Report 2022
Bundesamt für Statistik, Schweiz
Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.
PubMed 24201900Burket LW, Greenberg MS, Glick M. Burkett's Textbook of Oral Medicine. 10th ed. Philadelphia, PA: Lippincott
Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.
PubMed 4796576Tierney E, Lewis G, Hurtig JB, Johnson D. Femoral nerve block with bupivacaine 0.25 per cent for postoperative analgesia after open knee surgery. Can J Anaesth. 1987 Sep;34(5):455-8. doi: 10.1007/BF03014348.
PubMed 3664912Rosenblatt RM. Continuous femoral anesthesia for lower extremity surgery. Anesth Analg. 1980 Aug;59(8):631-2. No abstract available.
PubMed 7190803Edwards ND, Wright EM. Continuous low-dose 3-in-1 nerve blockade for postoperative pain relief after total knee replacement. Anesth Analg. 1992 Aug;75(2):265-7. doi: 10.1213/00000539-199208000-00020.
PubMed 1632541Ma HH, Chou TA, Tsai SW, Chen CF, Wu PK, Chen WM. The efficacy of continuous versus single-injection femoral nerve block in Total knee Arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2020 Feb 24;21(1):121. doi: 10.1186/s12891-020-3148-1.
PubMed 32093655Atkinson HD, Hamid I, Gupte CM, Russell RC, Handy JM. Postoperative fall after the use of the 3-in-1 femoral nerve block for knee surgery: a report of four cases. J Orthop Surg (Hong Kong). 2008 Dec;16(3):381-4. doi: 10.1177/230949900801600324.
PubMed 19126912Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
PubMed 19680735Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.
PubMed 19553071
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subsartorial Saphenous Nerve Block (SSNB) Versus Femoral Nerve Block (FNB) in Primary Total Knee Arthroplasty (TKA) Combined With Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK) - Where Are the Benefits?
- ClinicalTrials.gov ID
- NCT06074744
- Acronym / sponsor ID
- SSNB2023
- Conditions
- Joint Diseases, Joint Pain
- Keywords
- Subsartorial Saphenous Nerve Block (SSNB), Femoral Nerve Block (FNB), Total Knee Arthroplasty (TKA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (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.
The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is:
- is there a benefit in functional muscle power output of the leg?
Participants will be randomized into either the intervention group or the control group and:
- receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1)
- receive Femoral Nerve Block (FNB) + IPACK in control group (group 2)
Researchers will compare the 2 groups to see if there are differences in :
- functional muscle power output of the leg?
- muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?
Detailed description
Prospective, randomized, double-blinded, single-center, controlled clinical trial with intervention group (SSNB + IPACK, group 1) and control group (FNB + IPACK, group 2), randomization by sealed envelopes.
The number of participants will be 72 per group, calculated based on a sample size calculator program.
The 3 surgeons will be blinded as well as the patients regarding the nerve block they will receive.
We will explain to the patients how both the blocks will be carried out, that 1 block will be located "higher on the leg" and 1 "lower on the leg". The nerve blocks will be carried out by a well-trained anaesthesiologist following standard procedures preoperative.
The IPACK will be applied by the surgeons intraoperative, following a standard protocol. The used implant for all patients will be the cemented ATTUNE™ Primary Knee System® (DePuySynthes Johnson\&Johnson).
Every patient will wear a brace fixed in full extension after surgery for the first 24 hours. Postoperative all patients will receive a standard set of adequate analgesics.
The postoperative rehabilitation program will follow our well-established physiotherapy scheme.
Performed assessments:
- Range of motion (ROM)
- medical history
- physical examinations
- radiologic controls
- adverse events
- falls during hospital stay (standard protocol)
- pain assessment (numeric rating scale)
- Questionnaires (EQ-5D-5L und Oxford Knee Score) will be filled in by the patients
- Functional assessment: Cycle sprint test one a specially instrumented indoor bike (Verve Info Tec PTY LTD) fit with an instrumented crank (InfoCrank Power Meter, Verve Cycling, West Perth, Australia)
- Functional assessment: Manual muscle testing (MMT)
- Functional assessment: Timed up and go test (TUG)
Superiority analysis using a two sample t-test, significance level 0.05, power 80%.
Data will be stored electronically in the data base (RedCap). In case of missing data there will always be attempts to obtain these data afterwards (contacting the patients by phone). Further on statistical analysis is performed.
Dropouts, before the 6 weeks follow-up, will be replaced by recruitment of new subjects.
For quality assurance the sponsor, the Ethics Committee or an independent trial monitor may visit the research sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: SSNB + IPACK (group 1) | Active comparator | Other: SSNB + IPACKSubsartorial Nerve Block: * 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect * anatomic landmarks: proximal adductor channel, intersection of the medial borders of the sartorius muscle and the adductor longus, guided by ultrasound control * no patch to puncture site to not jeopardise the surgeon's blinding * IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation |
| Control group: FNB + IPACK (group 2) | Active comparator | Other: FNB + IPACKFemoral Nerve Block: * 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect * anatomic landmarks: lateral to the femoral artery,level of the femoral crease (proximal to the vascular outlet of the deep artery of the thigh), femoral nerve lies on the surface of the iliopsoas muscle and is covered by the fascia iliaca, guided by ultrasound control * no patch to puncture site to not jeopardise the surgeon's blinding * IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18yrs
- primary TKA
- BMI 35kg/m2 or less
- able to give informed consent as documented by signature
- clinical history without any contraindications for the planned intervention
Key exclusion criteria (8 listed)
- age < 18 years
- revision-TKA
- BMI >35kg/m2
- absent contact information
- inability or contraindications to undergo the investigated intervention (TKA, FNB, SSNB), - clinically significant concomitant diseases
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 |
|---|---|---|
| SSNB + IPACKAlso: Subsartorial Nerve Blockalready included in arm/group description | Other | Intervention group: SSNB + IPACK (group 1) |
| FNB + IPACKAlso: Femoral Nerve Blockalready included in arm/group description | Other | Control group: FNB + IPACK (group 2) |
Primary outcome
Functional muscle power output of the leg
Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Cycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better)
9 secondary outcomes
Muscle strength
Time frame: preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Mobility
Time frame: preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery
Clinical results
Time frame: preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery
Radiological results
Time frame: preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3)
Pain control
Time frame: before surgery, twice daily on the ward (except first 6 hours: hourly), day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Opioid consumption
Time frame: before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Length of hospital stay
Time frame: before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 1
Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 2
Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery
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 12 Mar 2024.
- BackgroundDeclaration of Helsinki, Version October 2013
- BackgroundInternational Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical Practice
- BackgroundInternational Conference on Harmonization (ICH, 1997) E8 Guideline: General Considerations for Clinical Trials
- BackgroundImplantatregister SIRIS Hüfte und Knie: Kurzfassung - SIRIS Report 2022
- BackgroundBundesamt für Statistik, Schweiz
- Background: PubMed 24201900Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.
- BackgroundBurket LW, Greenberg MS, Glick M. Burkett's Textbook of Oral Medicine. 10th ed. Philadelphia, PA: Lippincott
- Background: PubMed 4796576Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.
- Background: PubMed 3664912Tierney E, Lewis G, Hurtig JB, Johnson D. Femoral nerve block with bupivacaine 0.25 per cent for postoperative analgesia after open knee surgery. Can J Anaesth. 1987 Sep;34(5):455-8. doi: 10.1007/BF03014348.
- Background: PubMed 7190803Rosenblatt RM. Continuous femoral anesthesia for lower extremity surgery. Anesth Analg. 1980 Aug;59(8):631-2. No abstract available.
- Background: PubMed 1632541Edwards ND, Wright EM. Continuous low-dose 3-in-1 nerve blockade for postoperative pain relief after total knee replacement. Anesth Analg. 1992 Aug;75(2):265-7. doi: 10.1213/00000539-199208000-00020.
- Background: PubMed 32093655Ma HH, Chou TA, Tsai SW, Chen CF, Wu PK, Chen WM. The efficacy of continuous versus single-injection femoral nerve block in Total knee Arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2020 Feb 24;21(1):121. doi: 10.1186/s12891-020-3148-1.
- Individual participant dataSharing planned: No
Related trials for Joint Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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.
Judith Bering, Dr. med. principal investigator
Luzerner Kantonsspital Luzern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSNB + IPACK and FNB + IPACK in people with Joint Diseases and Joint Pain, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 8 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 12 Mar 2024. 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 Switzerland. 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 Judith Bering, Dr. med. (+41 41 205 18 91, judith.bering@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional muscle power output of the leg (time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery). 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 NCT06074744, which also lists 44 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 12 Mar 2024.