NCT05314985

Brief Summary

The objectives of this study are to investigate the feasibility primarily and furthermore the effects of a four to eight-weeks program of a combined clinic- and home-based preoperative physical therapy (exercise training and education) versus usual care in patients awaiting unilateral primary TKA up to 3 months after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

July 20, 2021

Last Update Submit

August 14, 2023

Conditions

Osteoarthritis, Knee

Keywords

Preoperative ExercisePhysical Therapy ModalitiesArthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • Preoperative functional performance compared to baseline

    To compare functional performance immediately pre-surgery after preoperative physical therapy in patients awaiting a TKA to baseline. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.

    2-10 days before sugery

Secondary Outcomes (40)

  • Preoperative functional performance compared to usual care

    2-10 days before sugery

  • Preoperative stair climbing before TKA compared to baseline

    2-10 days before sugery

  • Preoperative stair climbing before TKA compared to usual care

    2-10 days before sugery

  • Preoperative walking performance before TKA compared to baseline

    2-10 days before sugery

  • Preoperative walking performance before TKA compared to usual care

    2-10 days before sugery

  • +35 more secondary outcomes

Study Arms (2)

Prehab Group / Intervention Group

EXPERIMENTAL

4 to 8 weeks of preoperative physical therapy training and education intervention before total knee replacement surgery.

Other: Prehab intervention

Control Group

NO INTERVENTION

Usual care / no treatment before total knee replacement surgery.

Interventions

Prehab interventionOTHER

Individual training program containing strengthening, sensori-motor, joint mobilisation and endurance exercises as well as educational inputs concerning perioperative procedure and instructions on e.g. how to walk with crutches.

Prehab Group / Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male and female participants (≥18 years)
  • Patients receiving a unilateral TKA
  • Signed informed consent after being informed

You may not qualify if:

  • BMI \>35
  • Patella alta (Caton Deschamps Index \>1.2)
  • Muscle weakness due to neurological diagnosis
  • Known or suspected non-compliance
  • Known depression or other psychiatric disorders
  • Acute pain exacerbations or inflammation
  • Patellar instability
  • Contradictions on ethical grounds
  • Non-German speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Granicher P, Kocher M, de Bie R, Swanenburg J, Scherr J. Exploring feasibility of health-related quality of life assessments and pain diaries in patients undergoing prehabilitation before total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2025 Oct 23;26(1):988. doi: 10.1186/s12891-025-09184-9.

    PMID: 41131492DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Johannes Scherr, Prof.

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

April 7, 2022

Study Start

April 29, 2021

Primary Completion

September 30, 2022

Study Completion

April 30, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make Individual Participant Data (IPD) available.

Locations

CH(1)