FAldini Sport Total Joint Arthroplasty-Knee II

NCT06383936 | Recruiting DMC

• 1 other identifier: FAST-K II
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• number of patients returning to sports activities assessed by questionnaire

  1 year from the surgery

• clinical and functional outcomes measured as the variation in the Knee Society Score

  at 1, 3, 6 and 12 months from the surgery

Study Arms (1)

TKA patients

EXPERIMENTAL

Procedure: intensive rehabilitation after uncemented TKA

Interventions

intensive rehabilitation after uncemented TKA PROCEDURE

patients undergoing an intensive rehabilitation protocol after uncemented tka

TKA patients

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 40 and 65 years,
• both men and women,
• individuals who engaged in sports until knee pathology hindered them. - "Saltin-Grimby Physical Activity Level Scale" 3 or 4.

You may not qualify if:

• Patients with rheumatic and/or neuromuscular disorders.
• Patients with extreme knee deformity.
• Patients with secondary osteoarthritis with compromised bone quality.
• Patients with coronal knee instability.
• Pregnant patients.
• Patients with medical conditions or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 25, 2024
• Study Start: April 26, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

IT (1)