Assessment of Different Rehabilitation Treatments After a Partial Removal of the Meniscus

NCT01775345 | Unknown Phase 2 DMC

• 1 other identifier: MENFIS
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness. It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the current isotonic protocol.

Conditions

Rehabilitation Post-meniscectomy

Keywords

Partial meniscectomy; Physiotherapy; Isokinetics; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. The assessment will be comparative. It will be realized in both the affected knee and the healthy knee.

  We will observe the maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. Both the valuation and the work of muscular involution with isokinetic exercises will fulfil with an isokinetic dynamometer Biodex 3.

  7 weeks

Secondary Outcomes (1)

• Knee functionality with the Lysholm Test.

  7 weeks

Other Outcomes (2)

• Degree of pain with the Visual Analogue Scale (VAS).

  7 weeks

• Metabolomic biomarkers

  7 weeks

Study Arms (3)

Isotonic exercises + ST

EXPERIMENTAL

This group will realize 20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a maximum repetition (MR)(MR is the maximum resistance that a muscle can conquer). Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR.

Procedure: Isotonic exercises; Procedure: ST

Isokinetic exercises + ST

EXPERIMENTAL

This group will realize 20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.

Procedure: Isokinetic exercises; Procedure: ST

Isotonic and isokinetic exercises + ST

EXPERIMENTAL

This group will realize 20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.

Procedure: Isotonic and isokinetic exercises; Procedure: ST

Interventions

Isotonic exercises PROCEDURE

20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a MR. Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR.

Isotonic exercises + ST

Isokinetic exercises PROCEDURE

20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.

Isokinetic exercises + ST

Isotonic and isokinetic exercises PROCEDURE

20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1 MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.

Isotonic and isokinetic exercises + ST

ST PROCEDURE

Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)

Also known as: Standard therapy

Isokinetic exercises + ST; Isotonic and isokinetic exercises + ST; Isotonic exercises + ST

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women of between 18 and 60 years
• Surgical Intervention: partial meniscectomy of the internal meniscus
• Informed consent

You may not qualify if:

• Re-meniscectomy
• Associate injury of crossed ligaments
• Degenerative osteoarthritis of knee degree the II, III or IV
• Morbid obesity
• Infectious diseases in the skin, cutaneous injuries and / or zones of hypoesthesia
• Participants with malignant tumors
• Participants with cognitive or sensory alterations
• Volunteers who have taken part in a study in the last 3 months
• Lack of collaboration of the patient

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Hospital Universitari Sant Joan de Reus: collaborator

Study Sites (1)

Hospital Universitari Sant Joan

Reus, 43201, Spain

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carme Casajuana, PT

  Hospital Universitari Sant Joan de Reus

  STUDY DIRECTOR

Central Study Contacts

Carme Casajuana, PT

CONTACT

+34 977310300; ccasajuana@grupsagessa.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

ES (1)