Clinical trial NCT04587570: Rhizarthrosis 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhizarthrosis
Keywords: Rhizarthrosis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* diagnosed Rhizarthrosis

Exclusion Criteria:

* pregnancy and breastfeeding
* no signed Informed Consent

Primary outcomes:
measure: Change in perception of pain sensation in the thumb saddle joint
timeFrame: is measured 5 times, from screening visit to 3 months after intervention
Secondary outcomes:
measure: Change in force in the thumb saddle joint.
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
measure: Change in mobility of the thumb
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
measure: Change in quality of life score, assessed by Questionnaire SF36
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
measure: Change in Disabilities of Arm, Shoulder and Hand (DASH) Score
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
measure: Change in Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
measure: Change in movement in the thumb saddle joint.
timeFrame: is measured 5 times, from screening visit to 3 months after intervention.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz
state: Styria
Study officials:
affiliation: Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery
name: Lars-Peter Kamolz, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery
name: Raimund Winter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: