RhizarthrosisRHINCT04587570
Rhizarthrosis Study
A study testing Infiltration with PRP, Infiltration with Fat and Infiltration with PRP and Fat in people with Rhizarthrosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up to 25% of postmenopausal women. There are currently various conservative and surgical methods available for treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Infiltration with PRP, Infiltration with Fat and Infiltration with PRP and Fat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteAustria
- Study dates
- 22 May 2017to 8 Nov 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed Rhizarthrosis
Who cannot join
- pregnancy and breastfeeding
- no signed Informed Consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz
Graz, Styria, 8036
About this study
Official title: Injection of Platelet Rich Plasma and Autologous Fat Into the Thumb Carpometacarpal Joint for the Evaluation Their Potential Filling Effect in Patients With Osteoarthritis
Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up to 25% of postmenopausal women. There are currently various conservative and surgical methods available for treatment. If conservative treatment does not lead to freedom from pain, one of the surgical methods can be used, such as metacarpal extension osteotomy, trapeziectomy with or without ligamentoplasty, trapeziometacarpal arthrodesis, prosthesis implantation and various forms of interposition arthroplasty . Despite the high satisfaction rate of up to 95% after surgical treatment, the anatomy of the carpus is irreversibly destroyed . Apart from that, these operations are also associated with corresponding complications and post-operative immobilization of several weeks. Thus, a minimally invasive treatment method with a corresponding success rate would be of great advantage.
Hypothesis:
Read more
By infiltrating and filling the joint with Platelet-Rich Plasma (PRP), fat or a combination of both, the pain of rhizarthrosis can be reduced.
Aim of the study:
The aim of the announced doctoral thesis is to investigate the effect of PRP, lipofilling and its combination on arthroses of the thumb saddle joint after a single joint injection and to compare it with a control group.It is to be proven that PRP, fat and their combination lead to a different degree of pain relief compared to the control group due to the expansion of the joint space and the associated filling effect.
- Conditions
- Rhizarthrosis
- Being tested
- Infiltration with PRP, Infiltration with Fat, Infiltration with PRP and Fat, Infiltration with NaCl
- Keywords
- Rhizarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration with PRPProcedure or surgery
Infiltration with 1.5 ml PRP
Infiltration with FatProcedure or surgery
Infiltration with 1.5 ml Fat
Infiltration with PRP and FatProcedure or surgery
Infiltration with 0.75 ml PRP and 0.75 ml Fat
Infiltration with NaClProcedure or surgery
Infiltration with 1.5 ml NaCl
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Infiltration of PRP | Experimental | The proband gets Platelet Rich Plasma injected in the thumb saddle joint. Receives: Procedure: Infiltration with PRP |
| Group 2: Infiltration of Fat | Experimental | The proband gets fat injected in the thumb saddle joint. Receives: Procedure: Infiltration with Fat |
| Group 3: Infiltration of PRP and Fat | Experimental | The proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint. Receives: Procedure: Infiltration with PRP and Fat |
| Group 4: Infiltration of NaCl | Placebo comparator | The proband gets NaCl injected in the thumb saddle joint. Receives: Procedure: Infiltration with NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perception of pain sensation in the thumb saddle joint
assessed by VAS (Visual Analogue scale). The range goes from 0 (no pain) to 10 (worst imaginable pain).
Measured: is measured 5 times, from screening visit to 3 months after intervention
Secondary outcomes (6)
Change in force in the thumb saddle joint.
Evaluated by dynamometer: tweezergrip with Pinch-Gauge-Dynamometer, Crossgrip with Jamar-Dynamometer
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Change in mobility of the thumb
assessed by Kapandji-score, measured degrees of motion Dig I MCP, Dig I IP. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Change in quality of life score, assessed by Questionnaire SF36
The SF36 consists of 8 domains, the range of every scale goes from 0-100. A higher score indicates no restriction in health. 0 =greatest possible restriction of health; 100 = absence of health restrictions
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Change in Disabilities of Arm, Shoulder and Hand (DASH) Score
Upper-extremity disability and symptoms are assessed by the DASH-Score. The range goes from 0 (no disability) to 100.
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Change in Michigan Hand Outcomes Questionnaire (MHQ)
The MHQ has six domains. Overall hand function, activities of daily living (ADLs), work performance, aesthetics, and patient satisfaction) are scored from 0 - 100 in which 100 is the best possible ability.
The pain domain is scored from 0 - 100, where 0 indicates no pain.
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Change in movement in the thumb saddle joint.
lateralgrip of dump and index finger
Measured: is measured 5 times, from screening visit to 3 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 May 2017
- Primary completion1 Mar 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars-Peter Kamolz, Univ. Prof. Dr., Principal investigator, Medical University Graz, Department of Plastic, Aesthetic and Reconstructive SurgeryRaimund Winter, Dr., Principal investigator, Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587570
- Sponsor's protocol ID
- RHI01
- Acronym
- RHI
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Platelet Rich Plasma and Autologous Fat Into the Thumb Carpometacarpal Joint for the Evaluation Their Potential Filling Effect in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT04587570
- Acronym / sponsor ID
- RHI / RHI01
- Conditions
- Rhizarthrosis
- Keywords
- Rhizarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 14 Oct 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.
Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up to 25% of postmenopausal women. There are currently various conservative and surgical methods available for treatment. If conservative treatment does not lead to freedom from pain, one of the surgical methods can be used, such as metacarpal extension osteotomy, trapeziectomy with or without ligamentoplasty, trapeziometacarpal arthrodesis, prosthesis implantation and various forms of interposition arthroplasty . Despite the high satisfaction rate of up to 95% after surgical treatment, the anatomy of the carpus is irreversibly destroyed . Apart from that, these operations are also associated with corresponding complications and post-operative immobilization of several weeks. Thus, a minimally invasive treatment method with a corresponding success rate would be of great advantage.
Hypothesis:
By infiltrating and filling the joint with Platelet-Rich Plasma (PRP), fat or a combination of both, the pain of rhizarthrosis can be reduced.
Aim of the study:
The aim of the announced doctoral thesis is to investigate the effect of PRP, lipofilling and its combination on arthroses of the thumb saddle joint after a single joint injection and to compare it with a control group.It is to be proven that PRP, fat and their combination lead to a different degree of pain relief compared to the control group due to the expansion of the joint space and the associated filling effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Infiltration of PRP | Experimental | Procedure: Infiltration with PRPThe proband gets Platelet Rich Plasma injected in the thumb saddle joint. |
| Group 2: Infiltration of Fat | Experimental | Procedure: Infiltration with FatThe proband gets fat injected in the thumb saddle joint. |
| Group 3: Infiltration of PRP and Fat | Experimental | Procedure: Infiltration with PRP and FatThe proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint. |
| Group 4: Infiltration of NaCl | Placebo comparator | Procedure: Infiltration with NaClThe proband gets NaCl injected in the thumb saddle joint. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed Rhizarthrosis
Key exclusion criteria (2 listed)
- pregnancy and breastfeeding
- no signed Informed Consent
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 |
|---|---|---|
| Infiltration with PRPInfiltration with 1.5 ml PRP | Procedure or surgery | Group 1: Infiltration of PRP |
| Infiltration with FatInfiltration with 1.5 ml Fat | Procedure or surgery | Group 2: Infiltration of Fat |
| Infiltration with PRP and FatInfiltration with 0.75 ml PRP and 0.75 ml Fat | Procedure or surgery | Group 3: Infiltration of PRP and Fat |
| Infiltration with NaClInfiltration with 1.5 ml NaCl | Procedure or surgery | Group 4: Infiltration of NaCl |
Primary outcome
Change in perception of pain sensation in the thumb saddle joint
Time frame: is measured 5 times, from screening visit to 3 months after intervention
assessed by VAS (Visual Analogue scale). The range goes from 0 (no pain) to 10 (worst imaginable pain).
6 secondary outcomes
Change in force in the thumb saddle joint.
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Change in mobility of the thumb
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Change in quality of life score, assessed by Questionnaire SF36
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Change in Disabilities of Arm, Shoulder and Hand (DASH) Score
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Change in Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Change in movement in the thumb saddle joint.
Time frame: is measured 5 times, from screening visit to 3 months after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Rhizarthrosis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
RecruitingObservational study
Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy
Rhizarthrosis
Recruiting
The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery
Thumb Arthritis
Recruiting
High-Energy Laser in the Conservative Treatment of Rhizarthrosis
Thumb Osteoarthritis, Hand Injuries
RecruitingPhase 2
Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
Rhizarthrosis
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.
Lars-Peter Kamolz, Univ. Prof. Dr. principal investigator
Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery
Raimund Winter, Dr. principal investigator
Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration with PRP, Infiltration with Fat and Infiltration with PRP and Fat in people with Rhizarthrosis, run by Medical University of Graz at 1 site in Austria.
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 1 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: finished, as of the sponsor's last update on 9 Nov 2021. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perception of pain sensation in the thumb saddle joint (time frame: is measured 5 times, from screening visit to 3 months after intervention). 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 2021.