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Muscle Function Following Anterior Cruciate Ligament Reconstruction: Impaired Power Output in Physically Active Individuals (ReGAIN)

10. august 2026 oppdatert av: Centre Hospitalier Metropole Savoie

The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. The main questions it aims to answer is:

- Pre- and post-operative (6 months) changes in maximum knee extensor strength following ACL reconstruction, correlated with the IKDC-SKF score.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Before surgery :

  • The patient will undergo a series of assessment tests, including:
  • An assessment of the force-velocity and power-velocity relationships for each leg during a cycling task
  • An assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
  • An assessment of maximum strength and explosive strength in isometric (static) mode of the knee extensors.
  • A questionnaire-based assessment of IKDC-SKF scores. Evaluations will be repeated at 3 and 6 month after surgery ; Patients will be monitored for up to 24 months following their surgery

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Challes-les-Eaux, Frankrike, 73190
        • Rekruttering
        • Médipôle de Savoie
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients requiring isolated or complex ACL reconstruction (combined with a meniscal injury)
  • Patients who are physically active (Tegner score ≥ 4) and wish to resume such activity.
  • Patients with no history of surgery on the ipsilateral knee (i.e., native knee).
  • Patients able to comply with the study procedures
  • Patients who have given their free and informed written consent, having been informed of the purpose of the study, its procedure and its risks.
  • Be affiliated to a social security scheme.

Exclusion Criteria:

  • Patient with comprehension difficulties
  • Recurrent rupture of the ipsilateral ACL
  • Multi-ligament injuries (i.e., injury to the medial collateral ligament, lateral collateral ligament or posterior cruciate ligament)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: evaluated group
assessment of knee function before and after cruciate ligament surgery
Annen: assessment
  • Assessment of force-velocity and power-velocity relationships in each leg during a cycling task
  • Assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
  • Assessment of maximum force and explosive force in isometric (static) conditions of the knee extensors.
  • Measurement of scores using questionnaires (IKDC-SKF).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation of maximum knee extension strength to IKDC-SKF scores
Tidsramme: 6 month
Relationship (r coefficient) between 0-6 month delta of maximum knee extension strength measurements and International Knee Documentation Commitee-SKF scores (100: no limitation)
6 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peri-operatory trajectory of maximal dynamic force
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of F0 (maximal dynamic force) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of V0 (maximal contraction velocity) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
0, 3 and 6 month
Peri-operatory trajectory of rate of force development
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of rate of force development between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
0, 3 and 6 month
Peri-operatory trajectory of maximal isometric force
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of maximal isometric force (Fmax) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
0, 3 and 6 month
Peri-operatory trajectory of maximal dynamic force during cycling
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of maximal dynamic force (F0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity during cycling
Tidsramme: 0, 3 and 6 month
Trajectory of evolution of maximal contraction velocity (V0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
0, 3 and 6 month
Determinants of fonctional prognosis
Tidsramme: 0, 3 and 24 month

Multivariate analysis including the IKDC-SKF score at 24 months as dependant variable and, as predictors :

  1. the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
  2. the severity of the lesion (presence of associated lesions)
  3. the presence of a pre-operatory rehabilitation.
0, 3 and 24 month
Determinants of fonctional prognosis
Tidsramme: 0, 3 and 24 month

Multivariate analysis including the recurrence of ACL lesion at 24 months (0/1) as dependant variable and, as predictors :

  1. the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
  2. the severity of the lesion (presence of associated lesions)
  3. the presence of a pre-operatory rehabilitation.
0, 3 and 24 month
Determinants of fonctional prognosis
Tidsramme: 0, 3 and 24 month

Multivariate analysis including resuming physical activity at the pre-injury level at 24 months (0/1) as dependant variable and, as predictors :

  1. the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
  2. the severity of the lesion (presence of associated lesions)
  3. the presence of a pre-operatory rehabilitation.
0, 3 and 24 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Metropole Savoie

Samarbeidspartnere

Université Savoie Mont Blanc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. juni 2026

Primær fullføring (Antatt)

8. juni 2030

Studiet fullført (Antatt)

8. juni 2030

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHMS26001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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