Tibial Tubercle Distalisation and Accelerated Rehabilitation

NCT05854056 | Unknown DMC

• 1 other identifier: R22072
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patella Alta; Tibial Tubercle Distalisation Osteotomy; Rehabilitation

Keywords

Patella Alta; Tibial tubercle distalisation osteotomy; Accelerated rehabilitation

Outcome Measures

Primary Outcomes (1)

• The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.

  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 Outcomes (1)

• Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  measured at baseline, 6, 24 and 52 weeks postoperatively

Study Arms (2)

Accelerated rehabilitation protocol

ACTIVE COMPARATOR

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

Conservative rehabilitation protocol

ACTIVE COMPARATOR

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

Interventions

Accelerated rehabilitation protocol PROCEDURE

See Arms section

Accelerated rehabilitation protocol

Conservative rehabilitation protocol PROCEDURE

See Arms section

Conservative rehabilitation protocol

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Pihlajalinna Hospital, Tampere: collaborator

Related Publications (10)

• Biedert RM, Tscholl PM. Patella Alta: A Comprehensive Review of Current Knowledge. Am J Orthop (Belle Mead NJ). 2017 Nov/Dec;46(6):290-300.

  PMID: 29309446 BACKGROUND

• Insall J, Salvati E. Patella position in the normal knee joint. Radiology. 1971 Oct;101(1):101-4. doi: 10.1148/101.1.101. No abstract available.

  PMID: 5111961 BACKGROUND

• Caton J. [Method of measuring the height of the patella]. Acta Orthop Belg. 1989;55(3):385-6. French.

  PMID: 2603679 BACKGROUND

• Caton J, Mironneau A, Walch G, Levigne C, Michel CR. [Idiopathic high patella in adolescents. Apropos of 61 surgical cases]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(4):253-60. French.

  PMID: 2148403 BACKGROUND

• Sherman SL, Erickson BJ, Cvetanovich GL, Chalmers PN, Farr J 2nd, Bach BR Jr, Cole BJ. Tibial Tuberosity Osteotomy: Indications, Techniques, and Outcomes. Am J Sports Med. 2014 Aug;42(8):2006-17. doi: 10.1177/0363546513507423. Epub 2013 Nov 6.

  PMID: 24197613 BACKGROUND

• Ambra LF, Phan A, Gomoll AH. A New Technique for Distalization of the Tibial Tubercle That Allows Preservation of the Proximal Buttress. Orthop J Sports Med. 2018 Sep 25;6(9):2325967118798621. doi: 10.1177/2325967118798621. eCollection 2018 Sep.

  PMID: 30263901 BACKGROUND

• Mansourvar M, Ismail MA, Raj RG, Kareem SA, Aik S, Gunalan R, Antony CD. The applicability of Greulich and Pyle atlas to assess skeletal age for four ethnic groups. J Forensic Leg Med. 2014 Feb;22:26-9. doi: 10.1016/j.jflm.2013.11.011. Epub 2013 Dec 3.

  PMID: 24485416 BACKGROUND

• Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.

  PMID: 2302884 BACKGROUND

• Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.

  PMID: 19001484 BACKGROUND

• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

  PMID: 2805470 BACKGROUND

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Timo Rahnel

CONTACT

+3725233242; timorahnel@yahoo.com

Antti P Launonen

CONTACT

+358405508210; antti.launonen@pirha.fi

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: May 2, 2023
• First Posted: May 11, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share