Rhizarthrosis Study

Not Applicable

Completed

• Conditions: Rhizarthrosis
• Interventions: Procedure: Infiltration with Fat; Procedure: Infiltration with NaCl; Procedure: Infiltration with PRP; Procedure: Infiltration with PRP and Fat

• Registration Number: NCT04587570
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Primary Completion: 2021-03-01
• Status Verified: 2021-11
• Study Completion: 2021-11-08
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• diagnosed Rhizarthrosis

Exclusion Criteria

• pregnancy and breastfeeding
• no signed Informed Consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Infiltration of Fat	Infiltration with Fat	The proband gets fat injected in the thumb saddle joint.
Group 4: Infiltration of NaCl	Infiltration with NaCl	The proband gets NaCl injected in the thumb saddle joint.
Group 1: Infiltration of PRP	Infiltration with PRP	The proband gets Platelet Rich Plasma injected in the thumb saddle joint.
Group 3: Infiltration of PRP and Fat	Infiltration with PRP and Fat	The proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint.

Primary Outcome Measures

Name	Time	Method
Change in perception of pain sensation in the thumb saddle joint	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).

Secondary Outcome Measures

Name	Time	Method
Change in quality of life score, assessed by Questionnaire SF36	is measured 5 times, from screening visit to 3 months after intervention.	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
Change in Disabilities of Arm, Shoulder and Hand (DASH) Score	is measured 5 times, from screening visit to 3 months after intervention.	Upper-extremity disability and symptoms are assessed by the DASH-Score. The range goes from 0 (no disability) to 100.
Change in movement in the thumb saddle joint.	is measured 5 times, from screening visit to 3 months after intervention.	lateralgrip of dump and index finger
Change in force in the thumb saddle joint.	is measured 5 times, from screening visit to 3 months after intervention.	Evaluated by dynamometer: tweezergrip with Pinch-Gauge-Dynamometer, Crossgrip with Jamar-Dynamometer
Change in mobility of the thumb	is measured 5 times, from screening visit to 3 months after intervention.	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.
Change in Michigan Hand Outcomes Questionnaire (MHQ)	is measured 5 times, from screening visit to 3 months after intervention.	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.

Trial Locations

Locations (1)

Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz; 🇦🇹 Graz, Styria, Austria