Tibial Tubercle Distalisation and Accelerated Rehabilitation

May 2, 2023 updated by: Tampere University Hospital

Effect of Accelerated Postoperative Rehabilitation After Tibial Tubercle Distalisation: a Randomised Controlled Trial Protocol

The goal of this clinical trial is to compare in distalising tibial tubercle osteotomy procedure group fast rehabilitation to traditional rehabilitation.

The main questions it aims to answer are:

  • Will the novel accelerated rehabilitation protocol lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol?
  • Will the complication rate be similar in both groups?

Participants will be following fast rehabilitation or the traditional rehabilitation guidelines after distalising tibial tubercle osteotomy procedure according to the randomisation.

Researchers will compare fast rehabilitation group to the traditional rehabilitation group to see if recovery and functional outcome is improved in fast rehabilitation group and complication rate will be similar in both groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patella alta is a clinical condition where the patella is positioned too proximal in relation to the femoral trochlea. Such an abnormality may cause patellar instability and predispose to recurrent patellofemoral dislocations and patellofemoral pain. There are no conclusive guidelines for determining a threshold for too high positioned patella, as several different methods have been described to measure patellar height. As a surgical solution, distalising tibial tubercle osteotomy has been described to correct excessive patellar height.

In the early phase of the distalising tibial tubercle osteotomy postoperative protocol, weightbearing and knee flexion are limited with a brace commonly for 4-8 weeks. The potential risks for adverse effects associated with the limitation rehabilitation protocol include a delay in regaining knee range of motion, stiffness and muscle weakness. As a result, recovery from surgery is delayed and may lead to additional procedures and long-term morbidity in knee function.

This is a prospective, randomised, controlled, single-blinded, single centre trial comparing a novel accelerated rehabilitation protocol with the traditional, motion restricting rehabilitation protocol. All skeletally mature patients aged 35 years and younger, referred to as the distalising tibial tubercle osteotomy procedure group, are eligible for inclusion in the study. Patients will be randomised to either the fast rehabilitation group or the traditional rehabilitation group. Patients with patellar instability will be additionally treated with medial patellofemoral ligament reconstruction.

The hypothesis of the trial is that the novel accelerated rehabilitation protocol will lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol. A secondary hypothesis is that the complication rate will be similar in both groups.

The study will document short-term recovery and the planned follow-up will be 3 years. After the 1-year follow-up, the trial results will be disseminated in a major peer-reviewed orthopaedic publication.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic patella alta with recurrent dislocation or subluxation. Long-lasting anterior knee pain not responding to rehabilitation.

Exclusion Criteria:

Radiographic:

  • Open growth plates
  • Iwano [8] grade III and IV changes in patellofemoral joint
  • Caton-Deschamps <1.1 in MRI
  • PTI >50% in MRI
  • High grade trochlear dysplasia

General:

  • Refuses to participate in the study
  • Aged less than 15 or more than 35 years
  • Severe neurological, pulmonal or cardiovascular comorbidities that are contraindications for surgery
  • Lack of adequate co-operation
  • Does not adequately understand written and spoken instructions in the local language

Those patients who decline to take part in the trial will be asked to join a follow-up cohort as a background population. The patients in this follow-up cohort will be treated "as normal" without allocation, but the follow-up questionnaires will be the same as those given to the randomly assigned population. The patients in the follow-up cohort will also be asked to provide informed written consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Accelerated rehabilitation protocol
Elements of physical therapy Group 1 Accelerated rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations No Weight-bearing limitations No, crutches are recommended for 4 weeks. Active exercises. Functional exercises. 1 week Active dynamic strengthening exercises. 5 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks
Procedure: Accelerated rehabilitation protocol
See Arms section
Active Comparator: Conservative rehabilitation protocol

Elements of physical therapy Group 2 Conservative rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations 6 weeks Weight-bearing limitations 4 weeks limb weight, followed by half body weight till week 6

Active exercises. Functional exercises. 8 weeks Active dynamic strengthening exercises. 8 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks
Procedure: Conservative rehabilitation protocol
See Arms section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.
Time Frame: At 12 weeks
A difference of 10º in full range of movement will be considered significant. The results will be measured with a long goniometer in a standardised manner.
At 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time Frame: measured at baseline, 6, 24 and 52 weeks postoperatively
KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life. The baseline score from KOOS is recorded during the physiotherapist visit.
measured at baseline, 6, 24 and 52 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Pihlajalinna Hospital, Tampere

Investigators

  • Study Chair: Frederick Weitz, Pihlajalinna
  • Study Chair: Ville M Mattila, Prof, Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland
  • Study Chair: Erkki Nilkku, Pihlajalinna
  • Study Chair: Petri J Sillanpää, Pihlajalinna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R22072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The copyright of the trial research data will be owned and created by the participating research parties. The data will be shared among all participating researchers who will receive access to the data after the trial is completed. Due to confidentiality and legal agreements, public data sharing will be restricted because we only have permission to hold the data in the specific research server, not to transfer data. Under certain circumstances, for example, when a new member joins the collaboration, we will grant access to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rehabilitation

Clinical Trials on Accelerated rehabilitation protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe