Rhizarthrosis Study

NCT04587570 | Completed

• 1 other identifier: RHI01
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhizarthrosis

Keywords

Rhizarthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in force in the thumb saddle joint.

  is measured 5 times, from screening visit to 3 months after intervention.

• Change in mobility of the thumb

  is measured 5 times, from screening visit to 3 months after intervention.

• Change in quality of life score, assessed by Questionnaire SF36

  is measured 5 times, from screening visit to 3 months after intervention.

• Change in Disabilities of Arm, Shoulder and Hand (DASH) Score

  is measured 5 times, from screening visit to 3 months after intervention.

• Change in Michigan Hand Outcomes Questionnaire (MHQ)

  is measured 5 times, from screening visit to 3 months after intervention.

Study Arms (4)

Group 1: Infiltration of PRP

EXPERIMENTAL

The proband gets Platelet Rich Plasma injected in the thumb saddle joint.

Procedure: Infiltration with PRP

Group 2: Infiltration of Fat

EXPERIMENTAL

The proband gets fat injected in the thumb saddle joint.

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.

Procedure: Infiltration with PRP and Fat

Group 4: Infiltration of NaCl

PLACEBO COMPARATOR

The proband gets NaCl injected in the thumb saddle joint.

Procedure: Infiltration with NaCl

Interventions

Infiltration with PRP PROCEDURE

Infiltration with 1.5 ml PRP

Group 1: Infiltration of PRP

Infiltration with Fat PROCEDURE

Infiltration with 1.5 ml Fat

Group 2: Infiltration of Fat

Infiltration with PRP and Fat PROCEDURE

Infiltration with 0.75 ml PRP and 0.75 ml Fat

Group 3: Infiltration of PRP and Fat

Infiltration with NaCl PROCEDURE

Infiltration with 1.5 ml NaCl

Group 4: Infiltration of NaCl

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed Rhizarthrosis

You may not qualify if:

• pregnancy and breastfeeding
• no signed Informed Consent

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Interventions

CD36 Antigens

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: May 22, 2017
• Primary Completion: March 1, 2021
• Study Completion: November 8, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)