Rhizarthrosis Study (RHI)

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:

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 Overview

• Status: Completed
• Conditions: Rhizarthrosis
• Intervention / Treatment: Procedure: Infiltration with PRP; Procedure: Infiltration with Fat; Procedure: Infiltration with PRP and Fat; Procedure: Infiltration with NaCl

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed Rhizarthrosis

Exclusion Criteria:

• pregnancy and breastfeeding
• no signed Informed Consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Infiltration of PRP; The proband gets Platelet Rich Plasma injected in the thumb saddle joint.	Procedure: Infiltration with PRP; Infiltration with 1.5 ml PRP
Experimental: Group 2: Infiltration of Fat; The proband gets fat injected in the thumb saddle joint.	Procedure: Infiltration with Fat; Infiltration with 1.5 ml Fat
Experimental: Group 3: Infiltration of PRP and Fat; The proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint.	Procedure: Infiltration with PRP and Fat; Infiltration with 0.75 ml PRP and 0.75 ml Fat
Placebo Comparator: Group 4: Infiltration of NaCl; The proband gets NaCl injected in the thumb saddle joint.	Procedure: Infiltration with NaCl; Infiltration with 1.5 ml NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	is measured 5 times, from screening visit to 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in force in the thumb saddle joint.	Evaluated by dynamometer: tweezergrip with Pinch-Gauge-Dynamometer, Crossgrip with Jamar-Dynamometer	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.	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	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.	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.	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	is measured 5 times, from screening visit to 3 months after intervention.

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Lars-Peter Kamolz, Univ. Prof. Dr., Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery; Principal Investigator: Raimund Winter, Dr., Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rhizarthrosis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: RHI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No