Decrease of SPECT/CT uptake after SMOT

Decrease of 99mTc-HDP SPECT/CT uptake after supramalleolar osteotomy (SMOT) a pilot study - Optimal surgical correction in SMOT utilizing a AI prediction model based on two year clinical- and SPECT/CT follow up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58020

Enrollment

Registered

2025-02-28

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle osteoarthritis Degenerative joint disease of the ankle Ankle joint wear and tear Osteoarthrosis of the ankle

Interventions

SPECT/CT and long leg view

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: >18 years of ageSMOT of at least one ankle due to asymmetrical symptomatic ankle osteoarthritisAt least 2 years of follow-up after SMOT 

Exclusion criteria

Exclusion criteria: Patients with systemic arthritis because of an inflammatory medical conditionA sustained ipsilateral ankle trauma within 1 year of presentation of the first SPECT/CTA history of neurologic disease Foot and/or ankle surgery after SMOT (with exclusion of hardware removal)

Design outcomes

Primary

Measure	Time frame
The aim of this study is to determine if 99mTc-HDP SPECT/CT activity changes after SMOT in patients with asymmetrical symptomatic osteoarthritis. Change in radioisotope activity is defined as at least one grade of decreased of increased 99mTc-HDP SPECT/CT uptake (Hart et al.) per area (Raikin et al modified by Knupp et al.).	—

Secondary

Measure	Time frame
The secondary objectives are to identify explanatory variables associated with successful SMOT and to evaluate their correlation with 99mTc-HDP SPECT/CT uptake. Variables assessed are listed below. Secondary study parameters/endpoints. These explanatory variables may potentially serve in a future prediction model. Radiographic measurements Preoperative and PostoperativeHKA angle (hip-knee-ankle angle) (degrees)TT angle (talar tilt) (degrees)Ankle arthritis radiographic classification Takakura et al. 1-4 Anterior distal tibia angle (ADTA) (degrees)Medial distal tibia angle (MDTA) (degrees)Surgical accuracy compared to 3D planning (degrees)Ankle joint alignment: mechanical ankle joint axis point (MAJAP)  medial-neutral-lateral Haraguchi et al Surgery characteristicsCorrection wedge (type: open vs closed)Filling material (if applicable)Correction degree (degrees)Fixation plate (type)Osteotomy height (location)Ankle joint function and clinical scoresEQ5DNRS for pain 1-10In restWeightbearingNRS patient satisfaction 1-10NL FAOS 0-100 Sierevelt et al. AOFAS hindfoot 0-100 De Boer et al.	—

Measure

Time frame

The secondary objectives are to identify explanatory variables associated with successful SMOT and to evaluate their correlation with 99mTc-HDP SPECT/CT uptake. Variables assessed are listed below. Secondary study parameters/endpoints. These explanatory variables may potentially serve in a future prediction model. Radiographic measurements Preoperative and PostoperativeHKA angle (hip-knee-ankle angle) (degrees)TT angle (talar tilt) (degrees)Ankle arthritis radiographic classification Takakura et al. 1-4 Anterior distal tibia angle (ADTA) (degrees)Medial distal tibia angle (MDTA) (degrees)Surgical accuracy compared to 3D planning (degrees)Ankle joint alignment: mechanical ankle joint axis point (MAJAP)  medial-neutral-lateral Haraguchi et al Surgery characteristicsCorrection wedge (type: open vs closed)Filling material (if applicable)Correction degree (degrees)Fixation plate (type)Osteotomy height (location)Ankle joint function and clinical scoresEQ5DNRS for pain 1-10In restWeightbearingNRS patient satisfaction 1-10NL FAOS 0-100 Sierevelt et al. AOFAS hindfoot 0-100 De Boer et al. 

—

Countries

Netherlands

Contacts

Public ContactA.J. Hasselt

Martini Ziekenhuis

a.j.van.hasselt@umcg.nl050-5245970

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)