Wear of Articular Bearing Surface of Internal Prosthetic JointSHARPNCT04620395
Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure
A study testing Punch biopsy in people with Wear of Articular Bearing Surface of Internal Prosthetic Joint and Infection Prosthetic, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
Trial summary
The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wear of Articular Bearing Surface of Internal Prosthetic Joint, Infection Prosthetic, Infections Joint Prosthetic
- What is being tested?
- Punch biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- 20 Aug 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Preceding implantation of a shoulder, hip or knee endoprosthesis
- Acute or chronic pain in the joint
- Periprosthetic fracture
- Instability of the endoprosthesis
- Indications of wear / insufficiency of the enclosed plastic spacers
- Indications of metal abrasion
- Primary misalignment of the implant
Who cannot join
- Confirmed periprosthetic infection
- Proven allergy to fast-acting local anesthetics
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Vivantes Humboldt-Krankenhaus
Berlin, 13509
Karsten Labs, PD Dr. med., +4930130121655, karsten.labs@vivantes.de
Rafal J Borucki, MD, +4915129211687, rafal.borucki@vivantes.de
About this study
Official title: Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.
Read the detailed description
The main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. The subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. In addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm.
One of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. Furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.
- Conditions
- Wear of Articular Bearing Surface of Internal Prosthetic Joint, Infection Prosthetic, Infections Joint Prosthetic, Prosthetic Joint Infection, Prosthetic Pain
- Being tested
- Punch biopsy
- Keywords
- prosthetic joint, infection, wear particles, prosthetic failure, antibiotics, biopsy, joint tap
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch biopsyDiagnostic test
A standardized biopsy kit is used for a synovial fluid tap and subsequent acquisition of up to 7 Punch biopsies through an introducer (part of the kit)
| Study group | Role | What they receive |
|---|---|---|
| Joint tap | No intervention | Joint tap and aspiration of synovial fluid |
| Punch biopsy | Experimental | Punch biopsy of a prosthetic joint and extraction of 5-7 biopsies from the synovial membrane Receives: Diagnostic Test: Punch biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved diagnostic accuracy
Comparison of the specificity and sensibility of microbiological results for punch biopsies, the synovial fluid tap, pre-interventional blood Analysis, arthroscopic biopsies for confirmation/exclusion of a bacterial or fungal periprosthetic infection
Measured: up to 3 months
Secondary outcomes (5)
Rate of chronic periprosthetic low-grade-infections
The incidence of hidden chronic periprosthetic infections
Measured: up to 3 Months
Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision
Correlation of pre-revision microbiological findings and the samples taken during the endoprosthesis replacement operation, in particular the sonicate of the prosthesis and the periprosthetic membrane (gold standard for infection diagnostics)
Measured: up to 6 Months
Total Cost of Infection Diagnostics for various used methods
Comparison of the respective Overall Costs for diagnostics of acute and chronic periprosthetic infections using a joint-tap, the novel punch biopsy method and arthroscopic biopsy
Measured: 1 Month
Rate of prosthetic failure due to wear particles
Incidence of presence of wear particles in pathomorphological examinations of the punch biopsies and the samples taken during the replacement operation
Measured: up to 1 month
Correlation of Synovialitis score and microbiological findings
Correlation of Synovialitis score in pathomorphological examinations and microbiological verification of an acute or chronic periprosthetic infection
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start20 Aug 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear of Articular Bearing Surface of Internal Prosthetic JointStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karsten Labs, PD Dr, Study chair, Vivantes Humboldt Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620395
- Sponsor's protocol ID
- STUD.20-062
- Other IDs
- DRKS00022931, U1111-1257-2609
- Acronym
- SHARP
- Status last verified
- Nov 2020
- First submitted
- 25 Aug 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
- ClinicalTrials.gov ID
- NCT04620395
- Acronym / sponsor ID
- SHARP / STUD.20-062
- Conditions
- Wear of Articular Bearing Surface of Internal Prosthetic Joint, Infection Prosthetic, Infections Joint Prosthetic, Prosthetic Joint Infection, Prosthetic Pain
- Keywords
- prosthetic joint, infection, wear particles, prosthetic failure, antibiotics, biopsy, joint tap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbHUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Nov 2020 (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 aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.
Detailed description
The main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. The subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. In addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm.
One of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. Furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint tap | No intervention | –Joint tap and aspiration of synovial fluid |
| Punch biopsy | Experimental | Diagnostic Test: Punch biopsyPunch biopsy of a prosthetic joint and extraction of 5-7 biopsies from the synovial membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Preceding implantation of a shoulder, hip or knee endoprosthesis
- Acute or chronic pain in the joint
- Periprosthetic fracture
- Instability of the endoprosthesis
- Indications of wear / insufficiency of the enclosed plastic spacers
Key exclusion criteria (2 listed)
- Confirmed periprosthetic infection
- Proven allergy to fast-acting local anesthetics
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 |
|---|---|---|
| Punch biopsyA standardized biopsy kit is used for a synovial fluid tap and subsequent acquisition of up to 7 Punch biopsies through an introducer (part of the kit) | Diagnostic test | Punch biopsy |
Primary outcome
Improved diagnostic accuracy
Time frame: up to 3 months
Comparison of the specificity and sensibility of microbiological results for punch biopsies, the synovial fluid tap, pre-interventional blood Analysis, arthroscopic biopsies for confirmation/exclusion of a bacterial or fungal periprosthetic infection
5 secondary outcomes
Rate of chronic periprosthetic low-grade-infections
Time frame: up to 3 Months
Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision
Time frame: up to 6 Months
Total Cost of Infection Diagnostics for various used methods
Time frame: 1 Month
Rate of prosthetic failure due to wear particles
Time frame: up to 1 month
Correlation of Synovialitis score and microbiological findings
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Karsten Labs, PD Dr study chair
Vivantes Humboldt Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punch biopsy in people with Wear of Articular Bearing Surface of Internal Prosthetic Joint and Infection Prosthetic, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafal J Borucki, MD (+4915129211687, rafal.borucki@vivantes.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved diagnostic accuracy (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.