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Completed

NCT Number: NCT04587570

Rhizarthrosis Study

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.

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Key information

Conditions

Rhizarthrosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed Rhizarthrosis

Exclusion criteria

  • pregnancy and breastfeeding
  • no signed Informed Consent

Treatment and study plan

Infiltration with PRP

Procedure

Infiltration with 1.5 ml PRP

Infiltration with Fat

Procedure

Infiltration with 1.5 ml Fat

Infiltration with PRP and Fat

Procedure

Infiltration with 0.75 ml PRP and 0.75 ml Fat

Infiltration with NaCl

Procedure

Infiltration with 1.5 ml NaCl

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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. A higher score indicates no restriction in health. 0 =greatest possible restriction of health; 100 = absence of health restrictions

  4. 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.

  5. Change in Michigan Hand Outcomes Questionnaire (MHQ)

    Time frame: 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Acronym: RHI

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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