Rhizarthrosis Study

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Procedure: Infiltration with PRP
    • Infiltration with 1.5 ml PRP
  • Procedure: Infiltration with Fat
    • Infiltration with 1.5 ml Fat
  • Procedure: Infiltration with PRP and Fat
    • Infiltration with 0.75 ml PRP and 0.75 ml Fat
  • Procedure: Infiltration with NaCl
    • Infiltration with 1.5 ml NaCl

Arms, Groups and Cohorts

  • Experimental: Group 1: Infiltration of PRP
    • The proband gets Platelet Rich Plasma injected in the thumb saddle joint.
  • Experimental: Group 2: Infiltration of Fat
    • The proband gets fat injected in the thumb saddle joint.
  • 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.
  • Placebo Comparator: Group 4: Infiltration of NaCl
    • The proband gets NaCl injected in the thumb saddle joint.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • Change in force in the thumb saddle joint.
    • Time Frame: 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
    • Time Frame: 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 quality of life score, assessed by Questionnaire SF36
    • Time Frame: 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.
  • Change in Disabilities of Arm, Shoulder and Hand (DASH) Score
    • Time Frame: 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 Michigan Hand Questionnaire (MHQ) score
    • Time Frame: is measured 5 times, from screening visit to 3 months after intervention.
    • The MHQ contains six domains: overall hand function, activities of daily living, work performance, aesthetics, patient satisfaction, Pain
  • Change in movement in the thumb saddle joint.
    • Time Frame: is measured 5 times, from screening visit to 3 months after intervention.
    • lateralgrip of dump and index finger

Participating in This Clinical Trial

Inclusion Criteria

diagnosed Rhizarthrosis

Exclusion Criteria

pregnancy and breastfeeding,

no signed Informed Consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Graz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Raimund Winter, Dr., (+43 316) 385-81621, r.winter@medunigraz.at

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