Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

NCT04318197 | Terminated

• 1 other identifier: 29BRC.19.0154
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative rehabilitation before total knee arthroplasty (TKA) has not been proven to be effective. Latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. However, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. Pre-operative muscle atrophy, although not systematic, is often observed. The preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy. As part of the "FOLLOWKNEE" (RHU) project, which attempts to implement a personalized management of TKA and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before TKA.

Conditions

Gonarthrosis; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Difference of isometric strength D0-W4p

  Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W4 will be calculated as follows : (QSW4p-QSD0)+(HSW4p-HSD0). Personalized rehabilitation will first be compared to classic rehabilitation and if positive to global rehabilitation.

  Day 0 to Week 4 postoperative

Secondary Outcomes (7)

• Difference of isometric strength D0-W4

  Day 0 to Week 4

• Difference of isometric strength D0-W12p

  Day 0 to Week 12 postoperative

• Muscles volumes

  Day 0, Week 4, Week 2 postoperative

• Walking speed on 10 meters

  Day 0, Week 4, Week 4 postoperative, Week 12 postoperative

• Time up and go test (TUG)

  Day 0, Week 4, Week 4 postoperative, Week 12 postoperative

Study Arms (3)

Global rehabilitation

ACTIVE COMPARATOR

2 hours of daily rehabilitation, 3 days per week during 4 weeks

Other: Global rehabilitation program

Personalized rehabilitation

EXPERIMENTAL

2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks

Other: Personalized rehabilitation program with electrostimulation

Classic rehabilitation

NO INTERVENTION

40 minutes of rehabilitation, once a week during 4 weeks.

Interventions

Personalized rehabilitation program with electrostimulation OTHER

Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patients start a 2 hours daily rehabilitation including 2 times 20 minutes of electrostimulation of atrophied muscles, 3 days per week during 4 weeks.

Personalized rehabilitation

Global rehabilitation program OTHER

Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patient start a 2 hours daily rehabilitation targeting muscles groups with strengthening and stretching exercises, 3 days per week during 4 weeks.

Global rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Terminal stage gonarthrosis with total knee arthroplasty (TKA) indication
• TKA indicated by the surgeon
• Body Mass Index \< 35
• Acceptance to realize a preoperative rehabilitation in outpatient setting
• Adult between 18 and 80 years old
• Patient affiliated to social security
• Patient who signed an informed consent

You may not qualify if:

• Functionally uncomfortable osteoarticular illness (disabling pain, functional limitation of joint amplitudes or muscle strength) of controlateral leg.
• Unable or refusal to consent
• Contraindication to electrostimulation (skin lesion, nearby implanted metallic material, implanted cardiac or neurologic electrostimulator, intolerance to muscle electrical stimulation)
• Unstable medical situation preventing the continuous realization of a program of at least 4 weeks

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, France, 29200, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier REMY-NERIS, Pr

  University hospital of Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: December 18, 2020
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.

Locations

FR (1)